Clinical trial NCT06147973: An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
Official title: Wellness Achieved Through Changing Habits (WATCH): An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: adolescent obesity
cardiovascular disease risk
healthy lifestyle intervention
acceptance-based
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 148
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either an acceptance-based treatment intervention or a health education comparison for the duration of the study.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about cardiovascular disease risk among adolescent girls with overweight/obesity. The main questions this trial aims to answer are:

1. Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention?
2. Does an acceptance-based healthy lifestyle intervention show more improvements in participants' physiological, health-related, and psychological factors compared to a health education intervention?

Participants in this trial will:

1. Engage in treatment for 6-months, comprising of a mixture of in-person and remote group sessions, occurring at Drexel University or over a video-conferencing platform.
2. Complete various assessments. These include self-reported questionnaires, measures of weight, height, body composition, blood pressure, and blood lipids, and wearing of smart watches to measure sleep and physical activity.

Researchers will compare the acceptance-based and health education intervention groups to see if the acceptance-based treatment will indeed be effective in improving participants' health outcomes.

Detailed description: Overweight/obesity (OW/OB) affects 14 million adolescents in the U.S. and disproportionately affects girls and racial/ethnic minorities while increasing their risk of cardiovascular disease (CVD) and type 2 diabetes. Adolescents demonstrate limited self-regulation skills, which are essential for adhering to diet and physical activity goals. Adolescents must contend with pervasive biological and environmental cues (e.g., cravings, labor-saving devices) that promote overeating and sedentary behavior. There is a critical need for interventions that teach self-regulation to enable adolescents to respond adaptively to these cues. Acceptance-based therapy (ABT) is an innovative approach that focuses on self-regulation skills, mindfulness, and increasing tolerance of uncomfortable internal experiences. There is strong evidence for ABT as an effective weight loss intervention for adults. The investigators conducted formative work using an adolescent-engaged approach to develop, implement, and feasibility test an ABT intervention for adolescent girls with OW/OB. The objective of this proposal is to test the efficacy of a novel ABT weight loss intervention tailored for adolescent girls with OW/OB.

This trial is the first to investigate ABT tailored for adolescent girls with OW/OB. The investigators will conduct a 6-month, randomized controlled trial comparing ABT with a health education comparison for 14- to 19-year-old adolescent girls with OW/OB, including ≥40% racial/ethnic minorities. To enhance scalability, interventions in both conditions will be delivered by bachelor's level paraprofessional weight loss coaches, treatment will occur in a hybrid of in-person and remote sessions, and the trial will take place in an outpatient community clinic. Assessments will be conducted at baseline, mid-treatment (month 3), post-treatment (month 6), 6-month follow-up (month 12), and 12-month follow-up (month 18), for a total study time of 18 months. The primary hypothesis is that adolescents randomized to ABT will exhibit significantly greater improvements in BMI z-score post-treatment compared to a health education comparison (HE). In the secondary aims, the investigators hypothesize that at post-treatment and 6- and 12-month follow-up, adolescents randomized to ABT will exhibit significantly greater improvements in their physiological, behavioral, and psychological risk factors compared to HE.

Eligibility criteria: Inclusion Criteria:

* Ages 14-19
* Gender identification as girl
* BMI percentile ≥ 85th percentile for sex-and-age

Exclusion Criteria:

* Experience of weight loss of ≥5% of body weight in the past 6 months for any reason except post-partum weight loss
* Having recently begun or changed the dosage of any medication known to affect appetite or body composition within the last 3 months
* Plans to move out of the area within the next year
* Active cancer or cancer requiring treatment in the past 2 years (except non-melanoma skin cancer)
* Active or chronic infections (e.g., HIV or TB)
* Active cardiovascular disease or event including hospitalization or therapeutic procedures for treatment of heart disease in the past 6 months
* Active kidney disease
* History of bariatric surgery
* Lung disease: chronic obstructive airway disease requiring use of oxygen (e.g., emphysema or chronic bronchitis)
* Diagnosed diabetes (type 1 or 2)
* Any condition prohibiting physical activity
* Diagnosis of an eating disorder
* Have a mental handicap or are currently experiencing other severe psychopathology that would limit their ability to engage in the treatment program (e.g., severe depression, active psychotic disorder)
* Recent or ongoing problem with drug abuse, alcohol abuse, or addiction
* Currently pregnant or less than 3 months post-partum
* Anticipation of a possible pregnancy in the next year
* Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial

Primary outcomes:
measure: BMI z-score change
timeFrame: Month 6
Secondary outcomes:
measure: Physiological - Adiposity
timeFrame: Month 6, month 12, month 18
measure: Physiological - Blood pressure
timeFrame: Month 6, month 12, month 18
measure: Physiological - Blood lipids
timeFrame: Month 6, month 12, month 18
measure: Health-related behaviors - dietary intake
timeFrame: Month 6, month 12, month 18
measure: Health-related behaviors - physical activity
timeFrame: Month 6, month 12, month 18
measure: Psychological - Quality of life
timeFrame: Month 6, month 12, month 18
measure: Psychological - Depression
timeFrame: Month 6, month 12, month 18
measure: Psychological - Disordered eating
timeFrame: Month 6, month 12, month 18
measure: Psychological - Psychological flexibility
timeFrame: Month 6, month 12, month 18
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Stephanie Manasse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ogden CL, Carroll MD, Lawman HG, Fryar CD, Kruszon-Moran D, Kit BK, Flegal KM. Trends in Obesity Prevalence Among Children and Adolescents in the United States, 1988-1994 Through 2013-2014. JAMA. 2016 Jun 7;315(21):2292-9. doi: 10.1001/jama.2016.6361.
citation: Newsome FA, Cardel MI, Chi X, Lee AM, Miller D, Menon S, Janicke DM, Gurka MJ, Butryn ML, Manasse S. Wellness Achieved Through Changing Habits: A Randomized Controlled Trial of an Acceptance-Based Intervention for Adolescent Girls With Overweight or Obesity. Child Obes. 2023 Dec;19(8):525-534. doi: 10.1089/chi.2022.0116. Epub 2022 Nov 17.