Clinical trial NCT01324011: Family PALS (PArtners in Lifestyle Support)
Official title: Family Diabetes Study (Family PALS (PArtners in Lifestyle Support)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-03-28
Enrollment: 108
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: NOTE: This study is in the trial-phase of a 5-year study that included a formative research phase (Phase 1 - IRB study # 07-1765 "Family-based Diabetes Self-management Training for African American Adults"). During the first phase, eight focus groups were conducted with 68 participants and a validation study with 215 African American patients with type 2 diabetes. The data gathered in Phase 1 informs the refinement of the intervention in this phase.

Purpose: The overall goal of this research is to evaluate, in a randomized controlled trial, a family-based diabetes self-management intervention for overweight/obese African American adults with type 2 diabetes (the "index participants") and a paired overweight family member (co-participant) who does not have diabetes. The primary outcome is weight change in the index participant.

Detailed description: Type 2 diabetes disproportionately burdens African Americans, and already excessive rates of diabetes are expected to increase even further as rates of obesity rise. While there is evidence that diabetes self-management training is effective in improving metabolic control, and modest weight loss can delay the onset of diabetes, the investigators have limited knowledge of the best approach to self-management training from a family perspective in high risk groups such as African Americans. Family remains a valued dimension of African American life and may be an important behavioral context for interventions to improve disease management and health outcomes. Nonetheless, there are no trials of family-based interventions to improve diabetes self-care and achieve weight loss that have involved adult families.

Participants: A total of 80 pairs (index participant + family member) or 160 adults will participate in this trial where a 20-session behavioral weight loss intervention will be tested. Participants include overweight or obese African Americans with type 2 diabetes and a paired co-participant identified as an overweight or obese adult family member without type 2 diabetes. Family members may self-describe as non-African Americans.

Procedures (methods): Study participants will be enrolled in a randomized controlled trial using a 2:1 random allocation to the special intervention (a 20-session family-based behavioral weight loss intervention) or a usual care group (controls). Following the trial, participants in the usual care group will receive a 6-session weight management intervention (over a 2-month period) based on the 20-session special intervention.

Eligibility criteria: Person with diabetes.

Inclusion Criteria:

* self-described African American 21-75 years of age;
* self-reported diagnosis of type 2 diabetes;
* A1c value ≤ 11%;
* currently under the care of a physician or other health care provider;
* able to participate in moderate level physical activity;
* willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and physical activity patterns;
* access to a phone and willing to complete a telephone-administered survey;
* English speaking.

Exclusion Criteria:

* any medical contraindication to weight loss;
* cardiovascular event within the past 6 months;
* evidence of active cancer diagnosis;
* pregnant or lactating;
* self-reported history of renal disease other than kidney stones;
* any history of gastric bypass surgery or scheduled surgery for this purpose;
* weight loss of \>20 lbs in the last 3 months;
* current use of medications for weight loss, treatment of psychosis or manic-depressive illness.

Family Members: Inclusion criteria (NOTE: 'Family' for this study is defined as 'a group of intimates living together or in close proximity with strong emotional bonds (identification, attachment, loyalty, reciprocity, solidarity), and with strong, ongoing personal ties. Family members can only participate if paired with an African American study participant.):

* 21 -75 years of age;
* living with or married (for at least 1 year) to an African American adult diagnosed with diabetes;
* self-described as a blood relative of an African American with diabetes with whom there is regular, ongoing contact;
* overweight/obesity defined as a BMI between 25 to 47, inclusive;
* English-speaking;
* able to participate in moderate level physical activity;
* willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and physical activity patterns;
* access to a phone and willing to complete a telephone-administered survey.

Exclusion Criteria:

* self-reported diagnosis of type 2 diabetes (the A1c test used in this study cannot be used for diagnostic purposes; additionally, the initial therapy of most newly diagnosed patients with type 2 diabetes includes lifestyle changes and weight loss);
* any medical contraindication to weight loss;
* cardiovascular event within the past 6 months;
* evidence of active cancer diagnosis;
* pregnant or lactating;
* self-reported history of renal disease other than kidney stones;
* any history of gastric bypass surgery or scheduled surgery for this purpose;
* weight loss of \> 20 lbs in the last 3 months;
* current use of medications for weight loss, treatment of psychosis or manic-depressive illness.

Family members do not themselves have to be self-described African Americans.

Primary outcomes:
measure: Change in body weight
timeFrame: 6 months
Secondary outcomes:
measure: Effect on Hemoglobin A1c
timeFrame: 6 months (post-intervention)
measure: Lifestyle behaviors
timeFrame: 6 months
measure: Blood pressure change
timeFrame: 6 months
measure: Change in psychosocial factors
timeFrame: 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Health Promotion and Disease Prevention (HPDP)
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmen D. Samuel-Hodge, PhD
role: PRINCIPAL_INVESTIGATOR
References: