Family PALS (PArtners in Lifestyle Support)

NCT01324011 | Completed DMC

• 2 other identifiers: 10-1449K01DK080079
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Change in weight from start to end of the 20-weekly group-based intervention. NOTE: Weekly sessions are not held during weeks where holidays occur on a scheduled session date (such that the duration of the intervention may be more than 20 weeks).

  6 months

Secondary Outcomes (4)

• Effect on Hemoglobin A1c

  6 months (post-intervention)

• Lifestyle behaviors

  6 months

• Blood pressure change

  6 months

• Change in psychosocial factors

  6 months

Study Arms (2)

Family-based intervention

EXPERIMENTAL

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

Behavioral: Adult diabetes family-based weight loss intervention

Delayed intervention controls

OTHER

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.

Behavioral: Adult diabetes family-based weight loss intervention

Interventions

Adult diabetes family-based weight loss intervention 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.

Also known as: intense weight loss intervention, family-based lifestyle intervention

Delayed intervention controls; Family-based intervention

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UNC Center for Health Promotion and Disease Prevention (HPDP)

Chapel Hill, North Carolina, 27599-7426, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Carmen D. Samuel-Hodge, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 28, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 17, 2013

Record last verified: 2013-07

Locations

US (1)