Overweight and ObesityNCT06147973
An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
A study testing Acceptance-based Treatment (ABT) and Health Education (HE) Comparison in people with Overweight and Obesity, run by Nemours Children's Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Acceptance-based Treatment (ABT) and Health Education (HE) Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2024to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 14-19
- Gender identification as girl
- BMI percentile ≥ 85th percentile for sex-and-age
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Stephanie Manasse, PhD, 2155537157, smm522@drexel.edu
About this study
Official title: Wellness Achieved Through Changing Habits (WATCH): An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
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:
- Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention?
- Does an acceptance-based healthy lifestyle intervention show more improvements in participants' physiological, health-related, and psychological factors compared to a health education intervention?
Read more
Participants in this trial will:
- 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.
- 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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Acceptance-based Treatment (ABT), Health Education (HE) Comparison
- Keywords
- adolescent obesity, cardiovascular disease risk, healthy lifestyle intervention, acceptance-based
- Medical subject headings
- Overweight, Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-based Treatment (ABT)Behavioural
Participants will be provided with psycho-education, skill-builders, and other coaching to promote weight loss and healthy lifestyle changes.
Health Education (HE) ComparisonBehavioural
Participants will be provided with psych-education and resources to promote weight loss and healthy lifestyle changes. They will not be provided with directives.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance-based Treatment (ABT) | Experimental | ABT will consist of 18, 90-minute group sessions over 6 months. Receives: Behavioral: Acceptance-based Treatment (ABT) |
| Health Education (HE) Comparison | Sham comparator | HE will include nine, 75-minute group health education sessions handouts over 6 months. Receives: Behavioral: Health Education (HE) Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score change
Compare ABT vs. HE on BMI z-score change at post-treatment (month 6). The investigators hypothesize a significantly greater decrease in BMI z-scores in the ABT relative to HE.
Measured: Month 6
Secondary outcomes (9)
Physiological - Adiposity
Compare change in percent body fat in ABT relative to HE
Measured: Month 6, month 12, month 18
Physiological - Blood pressure
Compare change in diastolic and systolic blood pressure in ABT relative to HE
Measured: Month 6, month 12, month 18
Physiological - Blood lipids
Compare change in total blood lipid levels in ABT relative to HE. HDL, LDL, and total cholesterol will each be examined.
Measured: Month 6, month 12, month 18
Health-related behaviors - dietary intake
Compare change in dietary intake in ABT relative to HE. Dietary intake will be measured with a VioScreen Food Frequency Questionnaire.
Measured: Month 6, month 12, month 18
Health-related behaviors - physical activity
Compare change in physical activity in ABT relative to HE. Physical activity will be measured with a smart watch.
Measured: Month 6, month 12, month 18
Psychological - Quality of life
Compare change in quality of life, in ABT relative to HE. Quality of life will be measured with the Quality of Life Inventory.
Measured: Month 6, month 12, month 18
Psychological - Depression
Compare change in depression in ABT relative to HE at all time points. Depression will be measured using Beck's Depression Inventory-II.
Measured: Month 6, month 12, month 18
Psychological - Disordered eating
Compare change in disordered eating in ABT relative to HE at all time points. Disordered eating will be measured using the Eating Disorder Examination Questionnaire.
Measured: Month 6, month 12, month 18
Psychological - Psychological flexibility
Compare change in psychological flexibility in ABT relative to HE at all time points. Psychological flexibility will be measured using the Acceptance and Action Questionnaire II.
Measured: Month 6, month 12, month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start14 Feb 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either an acceptance-based treatment intervention or a health education comparison for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Manasse, Nemours Children's Clinic
- Investigators
- Stephanie Manasse, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147973
- Sponsor's protocol ID
- 2306009959
- Status last verified
- Jul 2026
- First submitted
- 10 Nov 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with the study Data Safety Monitoring Board (DSMB). Following study close-out, de-identified data and related data dictionaries will be available upon request.
Publications
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.
PubMed 27272581Newsome 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.
PubMed 36394498Manasse SM, Moussaoui JR, Lampe EW, Brown KL, Zhang F, Janicke DM, McCrea L, Cardel MI, Butryn ML. Evaluating an acceptance-based lifestyle modification program to address cardiovascular disease risk among adolescent girls with overweight and obesity: Protocol for a randomized controlled trial. Contemp Clin Trials. 2024 Sep;144:107634. doi: 10.1016/j.cct.2024.107634. Epub 2024 Jul 15.
PubMed 39019153
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness Achieved Through Changing Habits (WATCH): An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents
- ClinicalTrials.gov ID
- NCT06147973
- Acronym / sponsor ID
- 2306009959
- Conditions
- Overweight and Obesity
- Keywords
- adolescent obesity, cardiovascular disease risk, healthy lifestyle intervention, acceptance-based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention?
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either an acceptance-based treatment intervention or a health education comparison for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Acceptance-based Treatment (ABT) | Experimental | Behavioral: Acceptance-based Treatment (ABT)ABT will consist of 18, 90-minute group sessions over 6 months. |
| Health Education (HE) Comparison | Sham comparator | Behavioral: Health Education (HE) ComparisonHE will include nine, 75-minute group health education sessions handouts over 6 months. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Ages 14-19
- Gender identification as girl
- BMI percentile ≥ 85th percentile for sex-and-age
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance-based Treatment (ABT)Participants will be provided with psycho-education, skill-builders, and other coaching to promote weight loss and healthy lifestyle changes. | Behavioural | Acceptance-based Treatment (ABT) |
| Health Education (HE) ComparisonParticipants will be provided with psych-education and resources to promote weight loss and healthy lifestyle changes. They will not be provided with directives. | Behavioural | Health Education (HE) Comparison |
Primary outcome
BMI z-score change
Time frame: Month 6
Compare ABT vs. HE on BMI z-score change at post-treatment (month 6). The investigators hypothesize a significantly greater decrease in BMI z-scores in the ABT relative to HE.
9 secondary outcomes
Physiological - Adiposity
Time frame: Month 6, month 12, month 18
Physiological - Blood pressure
Time frame: Month 6, month 12, month 18
Physiological - Blood lipids
Time frame: Month 6, month 12, month 18
Health-related behaviors - dietary intake
Time frame: Month 6, month 12, month 18
Health-related behaviors - physical activity
Time frame: Month 6, month 12, month 18
Psychological - Quality of life
Time frame: Month 6, month 12, month 18
Psychological - Depression
Time frame: Month 6, month 12, month 18
Psychological - Disordered eating
Time frame: Month 6, month 12, month 18
Psychological - Psychological flexibility
Time frame: Month 6, month 12, month 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 27272581Ogden 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.
- Background: PubMed 36394498Newsome 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.
- Derived from this study: PubMed 39019153Manasse SM, Moussaoui JR, Lampe EW, Brown KL, Zhang F, Janicke DM, McCrea L, Cardel MI, Butryn ML. Evaluating an acceptance-based lifestyle modification program to address cardiovascular disease risk among adolescent girls with overweight and obesity: Protocol for a randomized controlled trial. Contemp Clin Trials. 2024 Sep;144:107634. doi: 10.1016/j.cct.2024.107634. Epub 2024 Jul 15.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with the study Data Safety Monitoring Board (DSMB). Following study close-out, de-identified data and related data dictionaries will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Manasse, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance-based Treatment (ABT) and Health Education (HE) Comparison in people with Overweight and Obesity, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Manasse, PhD (215-553-7157, smm522@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI z-score change (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06147973, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.