ObesityNCT01350531
Interventionist Procedures for Adherence to Weight Loss Recommendations in Black Adolescents
A study testing Skills training and Contingency Management in people with Obesity, run by Wayne State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Skills training and Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Rice contact
United States1 site, 1 recruiting
- Recruiting
Wayne State University
Detroit, Michigan, 48201
Shetoya Rice, 313-557-6556, srice1@med.wayne.edu
About this study
Official title: Interventionist Procedures for Adherence to Weight Loss Recommendations in Black Adolescents, Phase Two
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.
- Conditions
- Obesity
- Being tested
- Skills training, Contingency Management
- Keywords
- Obesity, African American adolescents, Motivation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills trainingBehavioural
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 ManagementBehavioural
Contingency management uses behavioral principles to counteract the reinforcing mechanisms of food and inactivity.
| Study group | Role | What they receive |
|---|---|---|
| Skills training | Experimental | Not described Receives: Behavioral: Skills training |
| Contingency Management | Experimental | Not described Receives: Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months, 9 months
Secondary outcomes (3)
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.
Measured: 6 months, 9 months
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.
Measured: 1 month, 7 months
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.
Measured: 6 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startSep 2009
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Investigators
- Sylvie Naar-King, Ph.D., Principal investigator, Wayne State UniversityK-L Cathy Jen, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350531
- Sponsor's protocol ID
- 1U01HL097889
- Status last verified
- Jan 2011
- First submitted
- 21 Apr 2011
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16097357Type 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.
PubMed 10868870Barlow 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.
PubMed 18055651Barlow 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.
PubMed 9724677Berwick DM. Disseminating innovations in health care. JAMA. 2003 Apr 16;289(15):1969-75. doi: 10.1001/jama.289.15.1969.
PubMed 12697800Block 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.
PubMed 2254769Naar 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.
PubMed 34435795Lee 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.
PubMed 33012663Jacques-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.
PubMed 30392864Hartlieb 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.
PubMed 25695260
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventionist Procedures for Adherence to Weight Loss Recommendations in Black Adolescents, Phase Two
- ClinicalTrials.gov ID
- NCT01350531
- Acronym / sponsor ID
- 1U01HL097889
- Conditions
- Obesity
- Keywords
- Obesity, African American adolescents, Motivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 9 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skills training | Experimental | Behavioral: Skills training |
| Contingency Management | Experimental | Behavioral: Contingency Management |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skills trainingThis 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). | Behavioural | Skills training |
| Contingency ManagementContingency management uses behavioral principles to counteract the reinforcing mechanisms of food and inactivity. | Behavioural | Contingency Management |
Primary outcome
Change from Baseline in weight-related outcomes at 6 months and 9 months
Time frame: 6 months, 9 months
We will be measuring participants' height, weight and percentage of body fat (Bioelectrical impedance analysis).
3 secondary outcomes
Change from Baseline in Adherence to Weight Loss Recommendations at 6 months and 9 months.
Time frame: 6 months, 9 months
Change in Physiological Functioning from month 1 to 7 months
Time frame: 1 month, 7 months
Change from Baseline in Motivation at 6 months and 9 months
Time frame: 6 months, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
- Background: PubMed 16097357Albrecht 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.
- Background: PubMed 10868870Type 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.
- Background: PubMed 18055651Barlow 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.
- Background: PubMed 9724677Barlow 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.
- Background: PubMed 12697800Berwick DM. Disseminating innovations in health care. JAMA. 2003 Apr 16;289(15):1969-75. doi: 10.1001/jama.289.15.1969.
- Background: PubMed 2254769Block 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.
- Derived from this study: PubMed 34435795Naar 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.
- Derived from this study: PubMed 33012663Lee 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.
- Derived from this study: PubMed 30392864Jacques-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.
- Derived from this study: PubMed 25695260Hartlieb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rice contact
Sylvie Naar-King, Ph.D. principal investigator
Wayne State University
K-L Cathy Jen, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills training and Contingency Management in people with Obesity, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Naar-King, Ph.D. (313-745-4875, naarkin@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in weight-related outcomes at 6 months and 9 months (time frame: 6 months, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01350531, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2011.