Family Practice 2011; 28:411

doi:10.1093/fampra/cmq069

The Author 2010. Published by Oxford University Press. All rights reserved.
For permissions, please e-mail: journals.permissions@oxfordjournals.org.

Advance Access published on 3 September 2010

Family intervention to control type 2 diabetes:

a controlled clinical trial
Diego Garca-Huidobro*, Marcela Bittner, Paulina Brahm and
Klaus Puschel
Family Medicine Department, Pontificia Universidad Catolica de Chile, Santiago, Chile.
*Correspondence to Diego Garca-Huidobro, Departamento de Medicina Familiar, Vicuna Mackenna 4686, Macul, Santiago,
Chile; E-mail: dgarciah@med.puc.cl
Received 22 February 2010; Revised 5 August 2010; Accepted 10 August 2010.

Purpose. Chilean patients with type 2 diabetes mellitus (T2DM) have a low rate of blood sugar
control. We studied the effectiveness of a culturally sensitive family oriented intervention designed to improve metabolic control in primary care patients with uncontrolled T2DM.
Methods. Patients with T2DM from three primary care clinics in Santiago, Chile were randomly
selected for inclusion if they had a recent HbA1c >7%, were between 18 and 70 years old and
lived with a family member. Patients from one clinic received the family oriented intervention;
patients from the other two (control) clinics received standard care. The intervention involved
family members in care and included family counselling during clinic visits, family meetings
and home visits. The primary outcome was HbA1c, measured at 6 and 12 months.
Results. A total of 243 patients were enrolled and 209 (86%) completed the study. The intervention was fully administered to only 34% of patients in the intervention clinic. The reduction in the
HbA1c from baseline to 12 months was not significantly different between clinics. During the
second 6-month period, when the intervention was more intensive, the patients in the intervention clinic significantly improved their HbA1c (P < 0.001) compared to the control patients.
Conclusions. A family intervention for the control of T2DM was associated with a significant reduction in HbA1c when the intervention was provided. Incomplete implementation, low statistical power and potential confounding variables between groups could be some of the main
factors that explain the lack of difference between clinics in the 12-month period.
Keywords. Family care, family intervention, primary care, type 2 diabetes mellitus.

this is not completely understood. Members of more

supportive families might have healthier behaviours,
higher medication adherence and lower levels of stress
that could explain their superior outcomes. Thus, involving family members may improve the management diabetes.
Despite this, few family interventions have been developed to improve control in patients with chronic
diseases. Morisky et al.16 studied hypertension and
demonstrated that counselling family members during
home visits improved appointment keeping, body
weight, blood pressure control and mortality after 5
years. In diabetes, interventions that include family
members have been associated with improvement in
metabolic control in type 1 diabetes mellitus but not
in T2DM.17 Therefore, the purpose of this study was
to assess the effectiveness of a culturally sensitive
family oriented intervention designed to improve metabolic control in primary care patients with uncontrolled T2DM.

Introduction
Type 2 diabetes mellitus (T2DM) is a health problem
worldwide, particularly in Latin America, where its
prevalence is expected to increase more than in other
parts of the world.1 In Chile, the prevalence of T2DM
is 4.2%.2 Although we have a lower rate of this disease than other nations, only 25% of patients have
HbA1c <7%, much lower than other Latin American
countries (43.2%),3 USA (40.5%)4 or Canada (51%).5
Different interventions have been developed to control diabetes in primary care without satisfactory results,6 indicating the need of new strategies for this
disease management.
Different factors, particularly psychosocial, influence the control of diabetes.710 Several of these pertain to family life and have been shown to correlate
with metabolic control. For instance, more family support and better family perception have been associated with better glycaemic control.1115 The cause of
4

Family intervention to control T2DM

Methods

patients and guidelines of the Chilean Ministry of

Health and use electronic records.

Setting
We used a controlled clinical trial in three primary
care clinics (Fig. 1). The clinics were located in an urban area in south-east Santiago, Chile. Two clinics
were part of the Primary Healthcare Network of the
Pontificia Universidad Catolica de Chile: Juan Pablo
II (intervention clinic) and San Alberto Hurtado (control clinic 1: CC1). Each of these clinics serves a population of 22 000 individuals and both are similar in
the quantity of human resources and types of health
programmes for diabetic patients. The intervention
clinic serves people with a monthly family income between USD 200 and 500, and the CC1, people with an
income between USD 500 and 1000 a month. The
third clinic, El Roble (control clinic 2: CC2), is a public
primary care clinic located near the intervention centre and administered by the local municipality. It
serves more people than the other clinics (35 000),
with similar socio-economic characteristics as those
served by the intervention clinic. It also has a similar
ratio of physicians and nurses to the population
served. The three clinics follow the structured care for

Sample
The sample consisted of patients with T2DM between
18 and 70 years old, with an HbA1c >7% in the preceding 3 months. Patients were randomly selected
from the databases of the clinics and were invited by
telephone or home visit to participate in the study. As
an inclusion criteria, patients had to live in the same
household with a significant family member >15 years.
Patients were excluded from the study if they were
hospitalized during the 3 months prior the HbA1c
measurement or had a cognitive disorder that limited
their participation.
The sample size was determined to provide a statistical power of 80%, a confidence interval of 95% and to
demonstrate an expected effect of a 10% decrease in
the HbA1c. We considered this magnitude of effect
because it has been associated with a 21% reduction
in T2DM-related morbidity and mortality.18 This analysis indicated that each centre had to include at least
72 patients.
Procedures
Trained interviewers asked patients for inclusion and
exclusion criteria. If the patient was eligible and
wanted to participate in the study, he or she was asked
to read and sign an informed consent agreement. Following this, the participants completed an in-person
interview, which was repeated at 12 months. HbA1c
was measured at 6 and 12 months after the intervention began. Baseline HbA1c was the value considered
for recruitment. All procedures and consent forms
were reviewed and approved by the Ethics Review
Board of the School of Medicine of the Pontificia Universidad Catolica de Chile.
Outcomes
The primary outcome variable was HbA1c at 12
months. Secondary outcomes were family functioning
style, depressive symptoms, health behaviours (diet
and exercise), medication adherence and knowledge
of diabetes.

FIGURE 1 Study design

Instruments
Assessments at baseline and 12 months included
a 138-item questionnaire. This survey was divided into
eight sections: diabetes and co-morbidities, medication
and adherence, use of health services, health behaviours, family and family functioning style, mood and
anxiety, diabetes knowledge and sociodemographics.
Family functioning style was measured with the
Family Functioning Style Scale validated in Chile.19
This instrument assesses seven family factors on a fivepoint scale and has been used in Chilean primary care.
Symptoms of depression and anxiety were assessed

Family Practicean international journal

with Goldbergs General Health Questionnaire validated in Chile.20 Medication adherence was assessed
with MoriskiGreen Scale validated in Spanish21 and
knowledge of diabetes with the Spanish version of the
Diabetes Knowledge Questionnaire-24.22
Intervention
The intervention was based in the Innovative Care for
Chronic Conditions Framework.23 This model is an
adaptation of the Chronic Care Model designed
by Wagner et al.24 to improve the control of chronic
diseases.
Family members were encouraged to be involved in
the care of their diabetic relatives (Fig. 1). By the end
of the intervention, each patient should have had participated in two interdisciplinary family meetings or
home visits where providers talked about family or
other psychosocial factors that could interfere with
their diabetes control. These activities were guided
through semi-structured interviews, and at the end of
the activities, patients and relatives signed an agreement making a commitment to change. To reinforce
the importance of the family, during home visits, families received a recipe book for diabetes and during family meetings, they received a framed family picture. In
addition, patients had to receive at least one individual
counselling session and one counselling session with
their relatives where the importance of family support
strategies were discussed. Also, during the 12-month
intervention period, patients and relatives were encouraged to attend multifamily group sessions, where health
behaviours and control strategies were discussed.
All providers of the intervention clinic were trained
in motivational interviewing and family counselling
and clinicians that guided multifamily groups were
trained in participative education for adults. Reports
about the fulfilment of the intervention and motivational activities were carried out monthly, where
health care teams that had the highest execution were
awarded.
As part of the intervention, the organization of the
clinic changed towards a family-oriented health centre.
All members of the health care team promoted family
participation in the care of T2DM patients. As example, medical assistants, pharmacists and administrative
staff counselled patients and family members when
measuring vital signs, dispensing medications or making appointments. Control patients only received the
usual care according to the guidelines for T2DM of
the Chilean Ministry of Health.
Statistical analysis
Data analysis was performed with SPSS software
v.16.1 (Chicago, IL). Per protocol and intention to
treat (ITT) analyses were performed. For the ITT
analysis, the last observation was carried forward
when there was a missing value of the outcome

studied, assuming an absence of variation in the results. For the analysis of changes in the outcomes between the final and baseline measures, we used
a paired t-test for continuous variables and McNemar
test for binary variables. To compare differences between health care centres, we used an analysis of variance and Bonferroni test for multiple comparisons of
continuous variables and a chi-square or Fishers exact
test for discrete variables. Potential confounders were
tested one at a time to model the change of the HbA1c.
We examined the following variables: age, illiteracy,
years of education, family income, insulin use, comorbidities, knowledge of diabetes and the presence of
depressive symptoms. A univariate analysis was performed to model the changes in HbA1c, considering
only the statistically significant baseline differences between health centres. Estimated marginal means were
analysed through the multiple comparison of Bonferroni.
Resulting two-tailed P-values of <0.05 were considered
statistically significant.

Results
Sample description
As seen in Figure 1, from a total of 433 eligible patients with uncontrolled T2DM, the sample included
243 patients (56.1%). Patients baseline characteristics
are summarized in Table 1. Most of them were
women, 50 years old and with a family income
<$250 USD per month. The initial HbA1c of patients
in the intervention centre was significantly higher than
the patients from both control centres. Compared to
the patients from the intervention clinic, CC1 patients
had more years of education, more family income,
fewer co-morbidities, better health behaviours, different type of diabetes treatment, greater knowledge of
diabetes and fewer depressive symptoms. Compared
to the intervention centre patients, CC2 patients were
older and more frequently illiterate, had fewer comorbidities and fewer depressive symptoms.
After 1 year of follow-up, 35 patients (14.4%) dropped out, mainly from CC1 (n = 19) because they could
not be found (n = 21, 60%) or because they moved
from their homes (n = 14, 40%). There were no significant differences in sex or age distribution among the
lost patients between health centres.
Outcomes
Table 2 shows the fulfilment of the main components
of intervention at 6 and 12 months. Only 28 patients
(34%) received all the proposed activities, mainly during the second 6-month period.
At 12 months, HbA1c was significantly reduced in
the intervention clinic from 10.3 to 9.2% (P < 0.001)
and in CC1 from 9.5 to 8.6% (P < 0.01). We did not
find statistically significant differences between health

Family intervention to control T2DM

TABLE 1 Baseline characteristics of patients
Intervention clinic (n = 83)

Control clinic 1 (n = 76)

61 (73)
53.4 (8.1)
16 (19)
5.8 (3.6)
41 (49)

50 (65)
53.5 (9.8)
2 (4)***
8.2 (3.6)***
10 (13)***

32 (39)
3.9 (2.4)
10.3 (2.0)

41 (53)
3.4 (1.7)
9.5 (2.2)*

29 (34)
4.0 (2.4)
9.3 (1.6)***

12 (15)
54 (65)
17 (20)

22 (28)
36 (47)
19 (25)

10 (12)
49 (58)
26 (31)

62 (90)
18 (26)

67 (88)
7 (9)*

75 (89)
20 (24)

2.1 (1.3)
18 (22)
2.1 (1.6)
1.2 (2.3)

2.0 (1.0)
8 (10) **
2.5 (1.6)
1.8 (2.4)

1.8
16
2.6
1.7

64 (77)
47 (57)
36 (43)
27 (33)
2.4 (0.8)
92.9 (12)
13.4 (3.1)
77 (93)

47 (61)***
38 (49)*
28 (36)*
24 (31)
2.4 (0.8)
93.7 (9.5)
14.5 (4.2)*
56 (73)***

Demographic characteristics
Women (%)
Age, years
Illiteracy (%)
Years of education
Family income below USD 250 (%)
Family
Patient lives with nuclear family (%)
Number of family members in the same house
HbA1c, %
Duration of diabetes diagnosis (years)
<1 (%)
110 (%)
>10 (%)
Treatment
Oral hypoglycemic medications (%)
Insulin (%)
Health behaviours
Breads per day
Use of sugar (%)
Fruits or vegetables per day
Physical activity (number of days per week)
Co-morbidities
Hypertension (%)
Dyslipidemia (%)
Obesity (%)
Smoking (%)
Medication adherence (Scale 14)a
Family functioning style (Scale 22110)a
Knowledge of diabetes (Scale 124)a
Presence of depressive symptoms (%)a

Control clinic 2 (n = 84)

53 (62)
56.2 (9.4)*
7 (9)**
6.2 (3.3)
47 (55)

(0.8)
(19)
(1.3)
(2.6)

68 (80)
42 (49)*
40 (47)
19 (22)**
2.4 (0.9)
92.7 (11.6)
12.7 (3.0)
66 (78)***

Data are presented at number (%) or mean (SD).

*P < 0.05, **P < 0.01, ***P < 0.001 compared to the intervention clinic.
a
Details of these scales can be obtained from the original publications.1821

TABLE 2

Intervention fulfilment

Component of
the family
intervention
Two interdisciplinary family meetings or home
visits
One interdisciplinary family meeting or home
visit
One individual family counselling session
One family counselling session with relatives
One multifamily educational session
Complete intervention

6 months 12 months
(%)
(%)

0 (0)

68 (82)

13 (12)

9 (11)

47 (57)
44 (53)
18 (22)
0 (0)

61 (74)
56 (68)
46 (56)
28 (34)

centres considering per protocol and ITT analyses. After adjusting for main baseline differences, the differences between clinics were still not significant (Fig. 2).
Because of the low intervention fulfilment during the
first 6-month period, we also analysed the HbA1c during the second part of the study, where most of the intervention was carried out (Table 3). Per protocol, ITT
and baseline adjusted analysis showed a statistically significant reduction in the HbA1c in the intervention
clinic compared to the CC1 (P < 0.001) and CC2 (P <

0.01). Regression analysis did not show differences between the different elements of the intervention in the
HbA1c.
We observed a significant reduction in depressive
symptoms in the intervention clinic compared to CC1
(Table 4). However, no significant changes occurred
at the intervention clinic and the control centres between baseline and 12 months in family functioning
style, health behaviours, medication adherence and
knowledge of diabetes. Also, all health clinics had similar changes in medication to control diabetes.
In addition, at the end of the study, we assessed the
satisfaction of patients and providers with the intervention provided. All providers considered the intervention to be globally useful for metabolic control.
Most patients (97%) perceived that the family orientation of the clinic and the family activities helped them
to manage the disease.

Discussion
Our trial showed a statistically significant reduction of
0.9% in HbA1c after the implementation of a family

Family Practicean international journal

FIGURE 2 Mean HbA1c at baseline, 6 and 12 months. HbA1c was adjusted for family income, years of education, depressive
symptoms and insulin use. CC1 indicates control clinic 1; CC2, control clinic 2
TABLE 3 HbA1c reduction during the second 6 months period in the participating clinics according statistical analysis

Per protocol analysis

Leaving out missing data
ITT analysis
Baseline adjusted analysisa

Intervention clinic

Control clinic 1

Control clinic 2

1.2 (2.2)
0.7 (2.3)
0.6 (2.1)
0.8 (2.1)

0.6 (1.1)***
0.4 (1.2)***
0.3 (1.1)***

0.2 (2.1)**
0.2 (2.0)**
0.3 (2.1)***

HbA1c was adjusted for family income, years of education, depressive symptoms and insulin use, with ITT analysis.
**P < 0.01, ***P < 0.001 compared with intervention clinic.

programme in the intervention clinic during 12

months. Only, when the intervention was more intensive, during the second 6-month period, the patients
in the intervention clinic significantly improved their
HbA1c compared to control patients (Table 3). Similar results were found in the meta-analysis of eight
clinical trials of family interventions for type 1 diabetes,
which showed a pooled effect of 0.6% reduction in the
HbA1c.17 Unfortunately, family interventions have not
shown improvement in the metabolic control of type 2
diabetes. Gilliland et al.25 reported an increase in the
HbA1c after 1 year of a lifestyle counselling programme that included families and friends. Although
all study groups had increases in the HbA1c, the increase in the intervention group was significantly lower
than in the control group. In a randomized clinical trial
involving patients with T2DM and obesity, a behavioural weight control programme that included spouses to
support their partners achieved a non-significant 1.2%
reduction in the HbA1c after 12 months.26 Even
though published studies have not demonstrated that
family interventions improve management of T2DM,
an additional trial and a systematic review are under
way because of the potential benefits.9,27
The effect on HbA1c observed in the intervention
clinic was similar to that in CC1 and not significantly
higher from that in CC2 during the whole trial period.
The lack of difference in the HbA1c reduction

between the intervention clinic and the two control

clinics could be explained by several factors. First, the
three cohorts were significantly different at baseline
in terms of socioe-conomic status, educational level,
co-morbidities, HbA1c, knowledge of diabetes and
presence of depressive symptoms (Table 1). All these
factors have been associated with diabetes control.2,79,28 However, after conducting single and multiple adjustments for these variables, there were still no
significant differences between groups (Fig. 2). Also,
because of the difference in response and follow-up
rates between centres, we think that we could have
had a potential selection bias in the sample.
Third, intervention fulfilment was incomplete. Only
34% of patients received all the proposed activities,
and most of these were administered during the second 6 months (Table 2). During this period, we observed a significant improvement in the metabolic
control compared to control patients (Table 3). Also,
the reduction of HbA1c was more important when patients completed all the elements of the intervention.
The success of this trial could be explained because of
the dose achieved during the second period of the trial
was more intensive than other studies that have assessed family interventions for T2DM.6,17,25,26 This
means that family orientation contributes to the metabolic control of T2DM patients but requires a high
dose of intervention to be significant. Since we

Family intervention to control T2DM

TABLE 4

Secondary outcomes at baseline and 12 months

Intervention clinic (n = 83)

Health behaviours
Breads per day
Use of sugar (%)
Fruits or vegetables per day
Physical activity (number of days per week)
Medication adherence (Scale 14)a
Family functioning style (Scale 22110)a
Knowledge of diabetes (Scale 124)a
Presence of depressive symptoms (%)a

Control clinic 1 (n = 76)

Control clinic 2 (n = 84)

Baseline

12 months

Baseline

12 months

Baseline

12 months

2.1 (1.3)
18 (22)
2.1 (1.6)
1.2 (2.3)
2.4 (0.8)
92.9 (12)
13.4 (3.1)
77 (93)

1.9 (0.9)
18 (22)
2.1 (1.3)
1.5 (1.2)
2.4 (1.1)
94.9 (13.8)
12.8 (3.5)
16 (20)***

2.0 (1.0)
8 (10)
2.5 (1.6)
1.8 (2.4)
2.4 (0.8)
93.7 (9.5)
14.5 (4.2)
56 (73)

2.0 (0.9)
6 (8)
2.1 (1.2)
1.5 (1.3)
2.6 (1.1)
93.1 (18.7)
13.2 (3.7)*
_T
_T
_
21 (29)***T

1.8 (0.8)
16 (19)
2.6 (1.3)
1.7 (2.6)
2.4 (0.9)
92.7 (11.6)
12.7 (3.0)
66 (78)

1.9 (0.7)
9 (11)
2.5 (1.7)
1.5 (1.1)
2.7 (1.2)*
97.1 (9.8)***
13.2 (2.2)*
12 (15)***

Data are presented at number (%) or mean (SD).

*P < 0.05, **P < 0.01, ***P < 0.001 compared to baseline value of the clinic.
_T
_T
_: P < 0.001 compared to the effect of the intervention clinic.
T
a
Details of these scales can be obtained from the original publications.1821

assessed a complex intervention, it is difficult to analyse which element worked better independently.
Many reasons could explain the lack of adherence to
the activities proposed across the year of the trial.
Since the intervention required an organizational
change, an initial time to adopt the intervention, confirm adherence to the new framework and correct mistakes should have been added at the beginning of the
trial.29 The health care team progressively learnt how
to administer the intervention over time, particularly
for the most important family activities: family meetings and home visits. Also, providers argued that the
duration of regular clinical appointments (15 minutes)
was too short to allow a family orientation. Although
a well-controlled study that directly compares individual patient and family modes of intervention has not
been reported, family-based care may be cost-efficient
and provide cost savings. Naylor et al.30 evaluated, in
hospitalized elderly patients, whether a comprehensive
discharge plan that addressed family care management
reduced readmissions, hospital length of stay, acute
care visits after discharge and costs. After 24 weeks,
the programme diminished admissions, length of hospital stays and costs. Future trials should consider the
dose of the family intervention provided and the barriers detected in this trial to achieve higher effectiveness and adherence to family-based programmes.
In our study, not only was the adherence of the intervention less than planned but so was its quality. Even
though all providers were trained in family assessment
and interview skills, time is required to fully develop
expertise in the family systems model. We used semistructured interviews to standardize activities, nonetheless, the interventions provided to different patients
and families across providers varied significantly. Recording family meetings or home visits and giving feedback to providers could have helped achieve a more
uniform intervention for all patients and families.

The ideal design to explore the effectiveness of

a complex intervention, such as the one proposed in
this study, is a cluster randomized controlled trial.31
Because we did not know the magnitude of effect
achievable with this strategy and estimated a high
level of contamination in the intervention centre, we
chose a controlled trial design instead of a randomized
trial as a pilot study. We selected the centres based on
similarities in the ways in which the clinics operated
(CC1) and the sociodemographic characteristics of the
patients (CC2). In spite of our efforts to choose the
best comparative centres, the baseline characteristics
of patients in both control clinics were substantially
different from the patients at the intervention centre,
and this naturally limited their comparison.
Our hypothesis was based on the idea that involving
family members through a set of family and educational activities could improve medication adherence,
health behaviours, knowledge of diabetes, family functioning style and depressive symptoms to finally improve the metabolic control of T2DM in 1 year. Since
few reported studies have been performed on family
interventions for the management of chronic diseases,
the type, dose and duration of the intervention needed
to produce changes in the studied outcome variables
are unknown. Our results showed a decreasing trend
in HbA1c levels mainly in the latter 6 months of the
study, when the intervention was more intense (Fig. 2,
Table 3). In spite of this tendency, the patients in the
intervention group did not show changes in the intermediate variables expected to ultimately improve metabolic control (Table 4). Further research is needed to
identify which factors are affected by families and
most likely to improve patient health.
Considering the importance of diabetes and the difficulties in achieving metabolic control, new strategies
need to be developed. Culturally sensitive interventions for patients with T2DM have improved disease

10

Family Practicean international journal

control in Hispanics and other populations.32,33 The

intervention that we used was developed based on the
views and values of patients, family members and providers. The high level of satisfaction with the programme reflects how the intervention considered local
beliefs and principles and was appropriate for patients
and providers. Future research should be based on culturally sensitive interventions.
In summary, the present study showed that when
the intervention was administered, it was associated
with a significant reduction in HbA1c, but the differences during the total research period did not reach
statistical significance. Lack of effectiveness, incomplete implementation, low statistical power and potential confounding variables between groups could be
some of the main factors that explain these results.

10

11

12

Acknowledgements

13

Nestle did not interfere with the study design, implementation, follow-up, analysis of results or published
data. This article was presented at the 19th World
Organization of Family Doctors (WONCA) World
Conference of Family Doctors during May 2010.

14

15

16

Declaration
Funding: Participating primary care clinics; the Southeast Metropolitan Health Service; Departments of
Family Medicine and Public Health of the School of
Medicine of the Pontificia Universidad Catolica de
Chile and Nestle.
Ethical approval: Ethics Review Board of the School
of Medicine of the Pontificia Universidad Catolica de
Chile (281/07).
Conflict of interest: none.

17

18

19

20

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