Interventionist Procedures for Adherence to Weight Loss Recommendations in Black Adolescents

NCT01350531 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-05-09

No results posted yet for this study

Summary

To date, attempts to construct effective weight loss interventions for African American adolescents with obesity (AAAO) have largely failed. While effective weight loss strategies and skills have been identified, lifestyle changes require youth and their families to learn new dietary and exercise behavior with repeated skills practice in natural ecology of the family. A major barrier is motivation of both parents and adolescents to engage in treatment and to adhere to behavior change recommendations. Advances in the science of increasing human motivation (both intrinsic and extrinsic) that could inform intervention development for minority youth with obesity have been insufficiently applied to date to the process of intervention development. The study brings together a multidisciplinary research group comprised of obesity intervention researchers with extensive experience in adolescent health behavior change research, basic behavioral scientists with experience in motivation and learning research and communication scientists with experience in provider-family interactions within urban populations. Basic science obesity researchers will inform intervention development by contributing a strong background in the physiological correlates of obesity. Finally experts in the area of community interventions for African American adolescents will contribute to the effective transport of these interventions to real-world settings. The overarching aims of the study are: To refine intervention protocols from our preliminary studies that maximize adolescent and parent skills, informed by learning theory, through the use of home and community-based interventions in which in-vivo opportunities are used to promote practice in making changes in dietary, exercise and sedentary behaviors in AAAO and their families (PHASE I); To develop intervention protocols that utilize findings from basic science regarding intrinsic and extrinsic motivation to maximize adolescent and family adherence to recommendations for obesity-related behavior change in AAAO and their families (PHASE I); To develop an adaptive intervention using a sequential multiple randomized assignment trial (SMART design) (PHASE II); To refine the intervention including qualitative analysis of interviews from participant families and to develop further community participation in preparation for a confirmatory randomized clinical trial (PHASE III).

There are two proposed hypotheses for this study:

1. Families initially receiving home/community delivery of Motivational Interviewing (MI)/skills training will show greater weight loss over the course of the study than families receiving initial office-based delivery of MI/skills training.
2. Non-responders receiving home/community delivery of MI/skills training with Contingency Management (CM) will show greater weight loss than non-responders receiving MI/skills training alone.

Conditions

Interventions

BEHAVIORAL

Skills training

This component includes skills most proximal to adhering to the eating and weight loss plan (e.g., calorie counting, making healthy food choices, measuring food portions, scheduling snacks and meals, meal planning, completing food logs daily, following an exercise plan).

BEHAVIORAL

Contingency Management

Contingency management uses behavioral principles to counteract the reinforcing mechanisms of food and inactivity.

Sponsors & Collaborators

  • Wayne State University

    lead OTHER

Principal Investigators

  • Sylvie Naar-King, Ph.D. · Wayne State University

  • K-L Cathy Jen, Ph.D. · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2014-06-30
Completion
2014-06-30

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 NCT01350531 on ClinicalTrials.gov