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Family PALS (PArtners in Lifestyle Support)

NCT01324011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2013-07-17

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

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

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Carmen D. Samuel-Hodge, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01324011 on ClinicalTrials.gov