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The Role of Parents in Adolescent Obesity Treatment (TEENS+)

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ClinicalTrials.gov Identifier: NCT02586090
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The study will pilot a randomized control trial to investigate the feasibility and preliminary efficacy of two distinct parent treatments on a dietary intervention for overweight and obese adolescents.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: Parents as Coaches Behavioral: Parent Weight Loss Not Applicable

Detailed Description:

Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and parent(s) (BMI >25 kg/m2). Families will participate in one of two 4-month treatments: 1) TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight management. All adolescents will participate in TEENS+, which includes behavioral support, nutrition education, and supervised physical activity.

For the adolescents, intervention will consist of weekly 1 hour exercise sessions and alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL). Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, post-test and 3-month follow-up.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Innovative Approaches to Adolescent Obesity Treatment: Exploring the Role of Parents
Actual Study Start Date : January 6, 2016
Actual Primary Completion Date : February 17, 2018
Actual Study Completion Date : February 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Parents as Coaches
PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.
Behavioral: Parents as Coaches
PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.

Experimental: Parent Weight Loss
In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program
Behavioral: Parent Weight Loss
In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program




Primary Outcome Measures :
  1. Between-group differences in parent weight change. [ Time Frame: 4 months (pre-intervention - post-test) ]
    Weight change (kg; parents)

  2. Within group differences in adolescent changes in BMI [ Time Frame: 4 months (pre-intervention - post-test) ]
    BMI change (kg/m2; adolescent)


Secondary Outcome Measures :
  1. Changes in parent dietary intake [ Time Frame: 4 months (pre-intervention - post-test) ]
    Average total energy intake (kcal/day) estimated via 3-day food record

  2. Changes in parent feeding practices measured via Child Feeding Questionnaire [ Time Frame: 4 months (pre-intervention - post-test) ]
  3. Changes in child dietary intake [ Time Frame: 4 months (pre-intervention - post-test) ]
    Average total energy intake (kcal/day) estimated via 3-day food record

  4. Changes in parent physical activity [ Time Frame: 4 months (pre-intervention - post-test) ]
    Mean total daily energy expenditure (kcal/day) estimated via accelerometer

  5. Changes in adolescent physical activity [ Time Frame: 4 months (pre-intervention - post-test) ]
    Mean total daily energy expenditure (kcal/day) estimated via accelerometer



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Adolescent Inclusion Criteria:

  • BMI ≥85% percentile for age and gender according to the CDC Growth Charts
  • Age 12 to 16
  • must reside with the primary participating parent
  • parent must have a BMI ≥25 kg/m 2
  • parent must be willing to participate in the protocol

Parent Inclusion Criteria:

  • 18-60 years of age
  • BMI ≥25 kg/m2
  • must reside with the adolescent

Exclusion Criteria:

Adolescent Exclusion Criteria

  • non-English speaking
  • medical condition(s) that may be associated with unintentional weight change
  • use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation;
  • medical condition(s) that may be negatively impacted by exercise
  • psychiatric, cognitive, physical or developmental conditions that would impair the ability to complete assessments, participate in a group, or conduct physical activity
  • reports of compensatory behaviors in the past 3 months
  • current pregnancy or plan to become pregnant during study period
  • previous participation in HM11113, HM13833, HM20003076, IRB3008, IRB6255, HM11390, HM13468, HM14973 or HM14139
  • current participation in another weight loss program; or 11) personal history of weight loss surgery.
  • clinically significant depression
  • clinically significant eating disorder
  • change in dose of metformin, oral contraceptives, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), or stimulant medications within 3 months prior to study participation.
  • weight in excess of 400 pounds
  • admission to a psychiatric hospital within the past year

Parent Exclusion Criteria

  • non-English speaking
  • medical condition(s) that may be associated with unintentional weight change
  • use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or investigational medications within 3 months of study participation
  • psychiatric, cognitive, physical or developmental conditions that would impair the parent's ability to respond to assessments, participate in physical activity or participate in a group
  • reports of compensatory behaviors in the past 3 months
  • current pregnancy, lactation, less than 6 months post-partum, or plan to become pregnant during the study period
  • past participation in IRB3354, HM11113, HM13833, HM20003076, IRB3008, IRB6255, HM11390, HM13468, HM14973 or HM14139
  • currently engaged in another weight loss program, or 9) personal history of weight loss surgery.
  • Severe depression or endorsing suicidal thoughts
  • admission to a psychiatric hospital within the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586090


Locations
United States, Virginia
Children's Hospital of Richmond at VCU Healthy Lifestyles Center
Henrico, Virginia, United States, 23239
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Melanie Bean, PhD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02586090     History of Changes
Other Study ID Numbers: HM20005235
PD304410 ( Other Identifier: VCU )
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Virginia Commonwealth University:
Pediatric Obesity
Lifestyle Intervention
Family-based Intervention
Motivational Interviewing

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms