Clinical trial NCT03851796: Parent Involvement in Adolescent Obesity Treatment
Official title: The Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Pediatric Obesity
Lifestyle Intervention
Family-based Intervention
Motivational Interviewing
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: University of Tennessee
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-02-22
Enrollment: 418
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

Brief summary: A randomized control trial to compare the efficacy of two distinct parent treatments on weight loss maintenance for adolescents with obesity participating in a lifestyle intervention including nutrition education, exercise and behavioral support.

Funding support from NIH via 1R01HD095910

Detailed description: Investigators will recruit adolescents with overweight or obesity (BMI\>85th percentile) and a parent (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 adolescents, the intervention will consist of weekly behavioral weight management group sessions and weekly 1 hour exercise sessions. Each adolescent also has a monthly individual session with a behavior coach. Parent groups meet weekly for 1 hour according to treatment arm (PAC or PWL). All PWL sessions are separate from their adolescent. Bi-weekly sessions in the PAC arm are combined with parents and adolescent. Assessments will consist of anthropometric measures, psychological surveys and dietary and PA evaluations. Assessments will be completed at baseline, 2 months, 4 months (post-test), 8 months and 1 year.

Eligibility criteria: Inclusion Criteria:

Adolescent Inclusion Criteria:

* BMI ≥ 85th percentile for age and gender according to the CDC Growth Charts
* Age 12 to 16
* Must reside with the primary participating parent

Parent Inclusion Criteria:

* ≥18
* 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
* Diabetes mellitus
* Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation
* Use of a GLP-1 within 6 months of study participation
* Use of Depo-Provera within 6 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 HM20010365, HM20003076, HM20005235 or HM20014304
* Current participation in another weight loss program
* Personal history of weight loss surgery
* Severe depression
* Clinically significant eating disorder
* Change in dose of metformin, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation
* 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 an investigational medication within 3 months of study participation
* Use of a GLP-1 within 6 months of study participation with no T2D diagnosis; if T2D diagnosis, change in dose GLP-1 within 3 months of study participation
* Use of Depo-Provera within 6 months of study participation
* 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, lactation, less than 6 months post-partum, or plan to become pregnant during study period
* Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304
* Current participation in another weight loss program
* Personal history of weight loss surgery
* Severe depression
* Clinically significant eating disorder
* Change in dose of diabetes medications, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation
* Admission to a psychiatric hospital within the past year

Primary outcomes:
measure: Adolescent weight loss maintenance
timeFrame: 8 months [4 month - 12 month follow up]
Secondary outcomes:
measure: Parent weight loss
timeFrame: 4 months [0 - 4 month]
measure: Physical activity
timeFrame: 8 months [4 months - 12 months]
measure: Dietary intake
timeFrame: 8 months [4 months - 12 months]
measure: Parenting Style
timeFrame: 4 months [0-4 month]
measure: Role Modeling
timeFrame: 4 months [0-4 month]
measure: Child Feeding
timeFrame: 4 months [0-4 month]
measure: Home Environment
timeFrame: 4 months [0-4 month]
measure: Weight control practices
timeFrame: 12 months [0-4 mo; 4-12 mo]
Other outcomes:
measure: Autonomy Support
timeFrame: 4 months [0-4 month]
measure: Parent Child Relationship
timeFrame: 4 months [0-4 month]
measure: Parent Self-efficacy
timeFrame: 4 months [0-4 month]
measure: Social Support
timeFrame: 4 months [0-4 month]
Locations:
city: Henrico
country: United States
facility: Children's Hospital of Richmond at VCU Healthy Lifestyles Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Melanie K Bean, PhD
role: PRINCIPAL_INVESTIGATOR
References: