The Role of Parents in Adolescent Obesity Treatment

Pediatric Obesity Clinical Trial

— TEENS+  

Official title:

Innovative Approaches to Adolescent Obesity Treatment: Exploring the Role of Parents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586090
• Other study ID #: HM20005235
• Secondary ID: 1R21HD084930
• Status: Completed
• Phase: N/A
• Start date: January 6, 2016
• Est. completion date: February 19, 2018

Study information

• Verified date: May 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: February 19, 2018
• Est. primary completion date: February 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Children's Hospital of Richmond at VCU Healthy Lifestyles Center	Henrico	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between-group differences in parent weight change.	Weight change (kg; parents)- primary outcome; trial is powered on parent weight change	4 months (pre-intervention - post-test)
Primary	Within group differences in adolescent changes in BMI	BMI change (kg/m2; adolescent)	4 months (pre-intervention - post-test)
Secondary	Changes in parent dietary intake	Average total energy intake (kcal/day) estimated via 3-day food record	4 months (pre-intervention - post-test)
Secondary	Changes in authoritative parenting (API) and parent feeding practices measured via Child Feeding Questionnaire	parenting and feeding style	4 months (pre-intervention - post-test)
Secondary	Changes in child dietary intake	Average total energy intake (kcal/day) estimated via 3-day food record	4 months (pre-intervention - post-test)
Secondary	Changes in parent physical activity	Mean total daily energy expenditure (kcal/day) estimated via accelerometer	4 months (pre-intervention - post-test)
Secondary	Changes in adolescent physical activity	Mean total daily energy expenditure (kcal/day) estimated via accelerometer	4 months (pre-intervention - post-test)