Family PALS (PArtners in Lifestyle Support)

NCT ID: NCT01324011

Last Updated: 2013-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Family-based intervention

Special intervention (20 weekly group-based sessions) to be compared with a delayed intervention control group.

Group Type: EXPERIMENTAL

Adult diabetes family-based weight loss intervention

Intervention Type: BEHAVIORAL

Participants assigned to the experimental group will begin the 2o-week weight loss intervention, while delayed intervention controls will wait until the end of this period to begin their program. The weight loss intervention includes 20 weekly group-based sessions facilitated by a registered dietitian. Each group session will last about 120 minutes and include: weight check, group sharing and problem-solving, discussion of a weight control topics (nutrition, physical activity, or behavior change), physical activity and/or taste-testing. Ten sessions will include a brief component, focused on improving family relationships for better diabetes self-care. The study weight loss goal is ≥10 pounds (minimum rate-0.5 lb/week; maximum-2 lbs/week). While the control group waits, they will receive 1 newsletter with study updates and general health or diabetes information. The delayed intervention includes 6 sessions (4 weekly + 2 bi-weekly) following the same format as the experimental group.

Delayed intervention controls

The delayed intervention controls will continue with usual care (if patients with diabetes)and at the end of the experimental period (6 months), they will receive a 6-session weight loss intervention delivered over a 2 month period.

Group Type: OTHER

Adult diabetes family-based weight loss intervention

Intervention Type: BEHAVIORAL

Participants assigned to the experimental group will begin the 2o-week weight loss intervention, while delayed intervention controls will wait until the end of this period to begin their program. The weight loss intervention includes 20 weekly group-based sessions facilitated by a registered dietitian. Each group session will last about 120 minutes and include: weight check, group sharing and problem-solving, discussion of a weight control topics (nutrition, physical activity, or behavior change), physical activity and/or taste-testing. Ten sessions will include a brief component, focused on improving family relationships for better diabetes self-care. The study weight loss goal is ≥10 pounds (minimum rate-0.5 lb/week; maximum-2 lbs/week). While the control group waits, they will receive 1 newsletter with study updates and general health or diabetes information. The delayed intervention includes 6 sessions (4 weekly + 2 bi-weekly) following the same format as the experimental group.

Interventions

Adult diabetes family-based weight loss intervention

Participants assigned to the experimental group will begin the 2o-week weight loss intervention, while delayed intervention controls will wait until the end of this period to begin their program. The weight loss intervention includes 20 weekly group-based sessions facilitated by a registered dietitian. Each group session will last about 120 minutes and include: weight check, group sharing and problem-solving, discussion of a weight control topics (nutrition, physical activity, or behavior change), physical activity and/or taste-testing. Ten sessions will include a brief component, focused on improving family relationships for better diabetes self-care. The study weight loss goal is ≥10 pounds (minimum rate-0.5 lb/week; maximum-2 lbs/week). While the control group waits, they will receive 1 newsletter with study updates and general health or diabetes information. The delayed intervention includes 6 sessions (4 weekly + 2 bi-weekly) following the same format as the experimental group.

Intervention Type: BEHAVIORAL

Other Intervention Names

intense weight loss intervention; family-based lifestyle intervention

Eligibility Criteria

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.

• 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

• 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.

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Carmen Samuel-Hodge, PhD

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmen D. Samuel-Hodge, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Center for Health Promotion and Disease Prevention (HPDP)

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

K01DK080079

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-1449

Identifier Type: -

Identifier Source: org_study_id