Acceptance-Based Treatment for Adolescent Obesity

Overseen By Stephanie Manasse, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Drexel University

Must not be taking: Appetite suppressants

Disqualifiers: Diabetes, Cancer, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: 6 months

148 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have recently started or changed the dosage of any medication that affects appetite or body composition, you may not be eligible to participate.

What data supports the effectiveness of the treatment Acceptance-Based Treatment for Adolescent Obesity?

Research shows that acceptance-based therapy (ABT) has been effective for weight loss in adults and is feasible and acceptable for adolescents. In a study, adolescent girls who participated in an ABT intervention showed a decrease in BMI and improvements in psychological flexibility compared to those who received enhanced care. ^{1 2 3 4 5}

Is Acceptance-Based Treatment safe for humans?

Acceptance-Based Treatment (ABT) has been studied for obesity in both adults and adolescents, and it has been found to be feasible and acceptable, indicating it is generally safe for humans. ^{1 2 3 4 6}

How is Acceptance-Based Treatment different from other treatments for adolescent obesity?

Acceptance-Based Treatment (ABT) for adolescent obesity is unique because it focuses on improving psychological flexibility and increasing physical activity intentions, rather than just providing standard lifestyle advice. It involves virtual group sessions that help adolescents accept their thoughts and feelings, which can lead to better weight management outcomes. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Research Team

Stephanie Manasse, PhD

Principal Investigator

Drexel University

Eligibility Criteria

This trial is for adolescent girls aged 14-19 who are experiencing obesity, with a BMI percentile at or above the 85th percentile for their sex and age. It's designed to help them lose weight and improve cardiovascular health.

Inclusion Criteria

My BMI is in the top 15% for my age and sex.

I am between 14 and 19 years old.

I identify as a girl.

Exclusion Criteria

Plans to move out of the area within the next year

Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial

Recent or ongoing problem with drug abuse, alcohol abuse, or addiction

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month intervention, including acceptance-based therapy or health education, with a mix of in-person and remote group sessions

6 months

18 sessions (in-person and remote for ABT), 9 sessions (in-person and remote for HE)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month and 12-month intervals

12 months

Assessments at month 12 and month 18

Treatment Details

Interventions

• Acceptance-Based Treatment

Trial Overview The study compares two methods: an acceptance-based healthy lifestyle intervention (ABT) versus standard health education (HE). Over six months, participants will attend both in-person and remote sessions to see which method leads to more weight loss and better health outcomes.

Participant Groups

Group I: Acceptance-based Treatment (ABT) Experimental Treatment 1 Intervention

ABT will consist of 18, 90-minute group sessions over 6 months.

Group II: Health Education (HE) Comparison Placebo Group 1 Intervention

HE will include nine, 75-minute group health education sessions handouts over 6 months.

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials

160

Recruited

48,600+

Findings from Research

Participants with overweight and obesity who underwent a revised acceptance-based behavioral treatment (ABT) lost significantly more weight over 12 months (13.3%) compared to those receiving standard behavioral treatment (SBT) (9.8%), indicating that ABT is more effective for long-term weight loss.

ABT not only led to greater weight loss but also helped participants maintain a 10% weight loss better than SBT (64.0% vs. 48.9%), suggesting that the self-regulation skills taught in ABT, such as psychological acceptance and motivation, play a crucial role in successful weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance-based versus standard behavioral treatment for obesity: Results from the mind your health randomized controlled trial. Forman, EM., Butryn, ML., Manasse, SM., et al.[2022]

The acceptance-based therapy (ABT) intervention for adolescent girls with overweight/obesity was feasible and acceptable, achieving a recruitment of 13 participants and an 85% retention rate over 6 months.

Participants showed a mean decrease in BMI Z-score of -0.15, along with improvements in body fat percentage, quality of life, psychological flexibility, and depression, indicating the intervention's potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility/acceptability of an acceptance-based therapy intervention for diverse adolescent girls with overweight/obesity. Cardel, MI., Lee, AM., Chi, X., et al.[2022]

In the Mind Your Health Trial involving 190 participants, acceptance-based treatment (ABT) for obesity led to a significantly higher proportion of individuals maintaining a 10% weight loss at 36 months compared to standard behavioral treatment (SBT) (31.6% vs. 17.1%).

ABT also resulted in improved quality of life at 24 and 36 months, suggesting that while initial weight loss benefits may diminish over time, the psychological and motivational aspects of ABT contribute to better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of the Mind Your Health Project: Acceptance-Based versus Standard Behavioral Treatment for Obesity. Forman, EM., Manasse, SM., Butryn, ML., et al.[2023]

In a pilot study involving 40 adolescent girls, the acceptance-based therapy (ABT) intervention led to a significant decrease in weight-related outcomes (%BMIp95) compared to enhanced care, suggesting its potential effectiveness for weight loss in this population.

While the ABT group showed improvements in psychological flexibility, the overall intervention effects were not significantly different from enhanced care, indicating that further research is needed to optimize ABT for adolescents, especially in virtual settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wellness Achieved Through Changing Habits: A Randomized Controlled Trial of an Acceptance-Based Intervention for Adolescent Girls With Overweight or Obesity. Newsome, FA., Cardel, MI., Chi, X., et al.[2023]

Acceptance-based behavioral treatment (ABT) led to significantly greater weight loss compared to standard behavioral treatment (SBT) when administered by experts, with participants losing an average of 13.17% versus 7.54% at post-treatment.

ABT was particularly effective for individuals more susceptible to eating cues, such as those with higher depression symptoms, showing a weight loss of 11.18% compared to 4.63% in SBT, highlighting the potential of ABT in enhancing weight loss outcomes for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. Forman, EM., Butryn, ML., Juarascio, AS., et al.[2022]

In a study of 162 adults with overweight or obesity, the acceptance-based behavioral intervention (ABBI) led to a greater maintenance of weight loss over 24 months compared to standard behavioral treatment (SBT), with participants regaining less weight after the initial treatment period.

ABBI participants were also more successful in achieving a 5% weight loss, with 38% reaching this goal compared to 25% in the SBT group, indicating that ABBI may be particularly effective for individuals with high internal disinhibition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of an acceptance-based behavioral intervention for weight loss in people with high internal disinhibition. Lillis, J., Niemeier, HM., Thomas, JG., et al.[2022]

Acceptance-based treatment (ABT) for weight loss significantly increased participants' intentions to engage in physical activity compared to standard behavioral treatment (SBT), with notable improvements observed at mid-treatment and the end of treatment.

The study found that higher intentions for physical activity partially mediated the weight loss effects of ABT, as participants who intended to be more active also increased their actual moderate-to-vigorous physical activity over the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention. Godfrey, KM., Schumacher, LM., Butryn, ML., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acceptance-based versus standard behavioral treatment for obesity: Results from the mind your health randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility/acceptability of an acceptance-based therapy intervention for diverse adolescent girls with overweight/obesity. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Long-Term Follow-up of the Mind Your Health Project: Acceptance-Based versus Standard Behavioral Treatment for Obesity. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Wellness Achieved Through Changing Habits: A Randomized Controlled Trial of an Acceptance-Based Intervention for Adolescent Girls With Overweight or Obesity. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The mind your health project: a randomized controlled trial of an innovative behavioral treatment for obesity. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of an acceptance-based behavioral intervention for weight loss in people with high internal disinhibition. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Physical Activity Intentions and Behavior Mediate Treatment Response in an Acceptance-Based Weight Loss Intervention. [2020]