Interventionist Procedures for Adherence to Weight Loss Recommendations in Black Adolescents

NCT ID: NCT01350531

Last Updated: 2011-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-06-30

Brief 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

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Skills training

Group Type: EXPERIMENTAL

Skills training

Intervention Type: BEHAVIORAL

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).

Contingency Management

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: BEHAVIORAL

Contingency Management

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. African American adolescents age range from 12 years to 16 years and 11 months with obesity (BMI>=95th percentile or BMI>30).

2. Adolescents may have primary obesity or obesity in combination with other medical co-morbidities.

3. Youth with mild mental retardation may be included if they are capable of reading and understanding the study measures.

Exclusion Criteria

1. Obesity secondary to medication use for another disorder;

2. Obesity in a youth with medical condition that prevents their participation in normal exercise;

3. African American adolescent with obesity (AAAO) with thought disorders;

4. AAAO with serious cognitive impairments;

5. AAAO who are pregnant or have a medical condition where weight loss is contraindicated;

6. AAAO who do not live with their primary caregiver.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Wayne State University

Principal Investigators

Sylvie Naar-King, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

K-L Cathy Jen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Wayne State University

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sylvie Naar-King, Ph.D.

Role: CONTACT

naarkin@med.wayne.edu

313-745-4875

Rice

Role: CONTACT

Facility Contacts

Shetoya Rice

Role: primary

srice1@med.wayne.edu

313-557-6556

References

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Other Identifiers

1U01HL097889

Identifier Type: NIH

Identifier Source: org_study_id

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