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Parental Involvement Strategies for Childhood Obesity (TEENS+ Trial)
N/A
Waitlist Available
Led By Melanie K Bean, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18
Age 12 to 16
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months [0-4 mo; 4-12 mo]
Awards & highlights
TEENS+ Trial Summary
This trial will compare the efficacy of two different parent treatments on weight loss maintenance for adolescents with obesity.
Who is the study for?
This trial is for families with an overweight adolescent (12-16 years old, BMI ≥ 85th percentile) and a parent (BMI ≥ 25 kg/m2). Both must live together and speak English. Excluded are those with severe depression, diabetes, certain medication use within the past few months, recent psychiatric hospital admission, or conditions affecting study participation.Check my eligibility
What is being tested?
The study tests two programs involving parents in adolescent obesity treatment: one where parents act as coaches and another where parents also aim to lose weight. It's a randomized control trial comparing these methods alongside lifestyle interventions for adolescents.See study design
What are the potential side effects?
Since this trial involves lifestyle changes rather than medications, side effects may include typical exercise-related issues such as muscle soreness or fatigue. Psychological impacts due to dietary changes or increased physical activity levels could also occur.
TEENS+ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am between 12 and 16 years old.
Select...
My BMI is in the top 15% for my age and gender.
TEENS+ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months [0-4 mo; 4-12 mo]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months [0-4 mo; 4-12 mo]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adolescent weight loss maintenance
Secondary outcome measures
Child Feeding
Dietary intake
Home Environment
+5 moreOther outcome measures
Autonomy Support
Parent Child Relationship
Parent Self-efficacy
+1 moreTEENS+ Trial Design
2Treatment groups
Active Control
Group I: TEENS+Parents as CoachesActive Control1 Intervention
Parents are taught strategies to support and facilitate child weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on strategies to facilitate healthy weight management in their child(ren). Topics include role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. They receive personalized feedback throughout the program.
All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents will receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program.
Group II: TEENS+Parent Weight LossActive Control1 Intervention
Parents are given a weight loss goal of 1-2 lbs/week, and specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program.
All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program.
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Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
698 Previous Clinical Trials
22,884,577 Total Patients Enrolled
University of North CarolinaOTHER
167 Previous Clinical Trials
1,449,209 Total Patients Enrolled
University of TennesseeOTHER
189 Previous Clinical Trials
141,611 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am an adolescent.I have had weight loss surgery in the past.I haven't changed my dose of metformin, antidepressants, or stimulants in the last 3 months.I am between 12 and 16 years old.You have engaged in behaviors to make up for something in the past 3 months.I haven't changed my diabetes, antidepressant, or stimulant medication doses in the last 3 months.I am not an adolescent.You have a serious eating disorder that affects your health.I have health issues that could worsen with exercise.I have not used a GLP-1 medication in the last 6 months.My BMI is in the top 15% for my age and gender.I have diabetes.I haven't used GLP-1 in the last 6 months without a T2D diagnosis; if I have T2D, my GLP-1 dose hasn't changed in 3 months.I have used Depo-Provera in the last 6 months.I have severe depression.I do not have any mental or physical conditions that would stop me from completing tasks or participating in activities.I haven't taken steroids, certain mental health meds, weight loss drugs, or experimental meds in the last 3 months.I have a health issue that might cause unexpected weight changes.
Research Study Groups:
This trial has the following groups:- Group 1: TEENS+Parents as Coaches
- Group 2: TEENS+Parent Weight Loss
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there available slots in this clinical experiment for participants?
"The most recent data on clinicaltrials.gov confirms that this study is still recruiting participants, with the original post date being May 23rd 2019 and the last update taking place November 1st 2022."
Answered by AI
How many participants are actively engaged in this research program?
"Affirmative. Evidenced on clinicaltrials.gov, this research trial is actively searching for volunteers to complete it. It was initially posted on May 23rd 2019 and last amended November 1st 2022, with 420 people required from a single medical centre."
Answered by AI
Is this research project restricted to individuals under 25 years old, or can those aged over 25 also participate?
"To be qualified for this trial, volunteers must fall between the ages of 12 and 16. A total 250 studies are planned for those under 18 years old while 603 are allocated to seniors aged 65 or above."
Answered by AI
What criteria must prospective participants meet to qualify for this research endeavor?
"The requirements to participate in this trial are an age range between 12 and 16, as well as a diagnosis of pediatric obesity. A maximum of 420 participants will be admitted into the study."
Answered by AI
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