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Interventionist Procedures for Adherence to Weight Loss Recommendations in Black Adolescents

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skills training
Contingency Management
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, African American adolescents, Motivation

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wayne State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Skills training

Contingency Management

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in weight-related outcomes at 6 months and 9 months
We will be measuring participants' height, weight and percentage of body fat (Bioelectrical impedance analysis).

Secondary Outcome Measures

Change from Baseline in Adherence to Weight Loss Recommendations at 6 months and 9 months.
Objective measures of cardiovascular fitness will be used in addition to the BLOCK Kids Food Frequency Questionnaire, and the Frequency of Fast Food Use Questionnaire.
Change in Physiological Functioning from month 1 to 7 months
Blood samples will be obtained after a 10-12 hour fast for measurement of plasma glucose, insulin, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglyceride levels.
Change from Baseline in Motivation at 6 months and 9 months
The Importance Ruler measure assesses how important different behaviors are to teens with regard to their weight loss. An analogous measure will be used to measure the importance of different behaviors in caregivers, as well.

Full Information

First Posted
April 21, 2011
Last Updated
May 6, 2011
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT01350531
Brief Title
Interventionist Procedures for Adherence to Weight Loss Recommendations in Black Adolescents
Official Title
Interventionist Procedures for Adherence to Weight Loss Recommendations in Black Adolescents, Phase Two
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Wayne State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, African American adolescents, Motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skills training
Arm Type
Experimental
Arm Title
Contingency Management
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Skills training
Intervention Description
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
Intervention Name(s)
Contingency Management
Intervention Description
Contingency management uses behavioral principles to counteract the reinforcing mechanisms of food and inactivity.
Primary Outcome Measure Information:
Title
Change from Baseline in weight-related outcomes at 6 months and 9 months
Description
We will be measuring participants' height, weight and percentage of body fat (Bioelectrical impedance analysis).
Time Frame
6 months, 9 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Adherence to Weight Loss Recommendations at 6 months and 9 months.
Description
Objective measures of cardiovascular fitness will be used in addition to the BLOCK Kids Food Frequency Questionnaire, and the Frequency of Fast Food Use Questionnaire.
Time Frame
6 months, 9 months
Title
Change in Physiological Functioning from month 1 to 7 months
Description
Blood samples will be obtained after a 10-12 hour fast for measurement of plasma glucose, insulin, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglyceride levels.
Time Frame
1 month, 7 months
Title
Change from Baseline in Motivation at 6 months and 9 months
Description
The Importance Ruler measure assesses how important different behaviors are to teens with regard to their weight loss. An analogous measure will be used to measure the importance of different behaviors in caregivers, as well.
Time Frame
6 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: African American adolescents age range from 12 years to 16 years and 11 months with obesity (BMI>=95th percentile or BMI>30). Adolescents may have primary obesity or obesity in combination with other medical co-morbidities. Youth with mild mental retardation may be included if they are capable of reading and understanding the study measures. Exclusion Criteria: Obesity secondary to medication use for another disorder; Obesity in a youth with medical condition that prevents their participation in normal exercise; African American adolescent with obesity (AAAO) with thought disorders; AAAO with serious cognitive impairments; AAAO who are pregnant or have a medical condition where weight loss is contraindicated; AAAO who do not live with their primary caregiver.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie Naar-King, Ph.D.
Phone
313-745-4875
Email
naarkin@med.wayne.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Naar-King, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
K-L Cathy Jen, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shetoya Rice
Phone
313-557-6556
Email
srice1@med.wayne.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
16097357
Citation
Albrecht TL, Ruckdeschel JC, Ray FL 3rd, Pethe BJ, Riddle DL, Strohm J, Penner LA, Coovert MD, Quinn G, Blanchard CG. A portable, unobtrusive device for videorecording clinical interactions. Behav Res Methods. 2005 Feb;37(1):165-9. doi: 10.3758/bf03206411.
Results Reference
background
PubMed Identifier
10868870
Citation
Type 2 diabetes in children and adolescents. American Diabetes Association. Diabetes Care. 2000 Mar;23(3):381-9. doi: 10.2337/diacare.23.3.381. No abstract available.
Results Reference
background
PubMed Identifier
18055651
Citation
Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
Results Reference
background
PubMed Identifier
9724677
Citation
Barlow SE, Dietz WH. Obesity evaluation and treatment: Expert Committee recommendations. The Maternal and Child Health Bureau, Health Resources and Services Administration and the Department of Health and Human Services. Pediatrics. 1998 Sep;102(3):E29. doi: 10.1542/peds.102.3.e29.
Results Reference
background
PubMed Identifier
12697800
Citation
Berwick DM. Disseminating innovations in health care. JAMA. 2003 Apr 16;289(15):1969-75. doi: 10.1001/jama.289.15.1969.
Results Reference
background
PubMed Identifier
2254769
Citation
Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol. 1990;43(12):1327-35. doi: 10.1016/0895-4356(90)90099-b.
Results Reference
background
PubMed Identifier
34435795
Citation
Naar S, Chapman J, Cunningham PB, Ellis D, MacDonell K, Todd L. Development of the Motivational Interviewing Coach Rating Scale (MI-CRS) for health equity implementation contexts. Health Psychol. 2021 Jul;40(7):439-449. doi: 10.1037/hea0001064.
Results Reference
derived
PubMed Identifier
33012663
Citation
Lee MS, Carcone AI, Ko L, Kulik N, Ellis DA, Naar S. Managing Outliers in Adolescent Food Frequency Questionnaire Data. J Nutr Educ Behav. 2021 Jan;53(1):28-35. doi: 10.1016/j.jneb.2020.08.002. Epub 2020 Oct 1.
Results Reference
derived
PubMed Identifier
30392864
Citation
Jacques-Tiura AJ, Ellis DA, Idalski Carcone A, Naar S, Brogan Hartlieb K, Towner EK, N Templin T, Jen KC. African-American Adolescents' Weight Loss Skills Utilization: Effects on Weight Change in a Sequential Multiple Assignment Randomized Trial. J Adolesc Health. 2019 Mar;64(3):355-361. doi: 10.1016/j.jadohealth.2018.09.003. Epub 2018 Nov 2.
Results Reference
derived
PubMed Identifier
25695260
Citation
Hartlieb KB, Jacques-Tiura AJ, Naar-King S, Ellis DA, Jen KL, Marshall S. Recruitment strategies and the retention of obese urban racial/ethnic minority adolescents in clinical trials: the FIT families project, Michigan, 2010-2014. Prev Chronic Dis. 2015 Feb 19;12:E22. doi: 10.5888/pcd12.140409.
Results Reference
derived

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Interventionist Procedures for Adherence to Weight Loss Recommendations in Black Adolescents

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