Overweight AdolescentsREACHNCT04848532
Problematic Decision-Making and Adolescent Weight Loss
A study testing Weight loss treatment in people with Overweight Adolescents and Overweight or Obesity, run by Drexel University at 1 site in United States.
Trial summary
This study evaluates the associations between baseline decision-making processes, engagement in problematic dietary practices, and post-intervention weight loss outcomes among adolescents. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Overweight Adolescents, Overweight or Obesity, Impulsive Behavior
- What is being tested?
- Weight loss treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Are between 14 and 18 years of age
- Have a BMI between the 85th and 99th percentiles for sex and age as determined by the CDC growth charts
- Are currently living at home with a parent or guardian
- Have at least one parent or guardian who is willing to participate in the study
- Are willing to complete baseline assessment tasks
- Have a smartphone, are willing to download an app to track food intake and complete surveys on the phone for two seven-day periods throughout the course of the study, and are willing to wear a fitness tracker during these same two week-long periods
- Are located in the US and wiling/able to participate in remote intervention and assessments
Who cannot join
- Acute suicide risk
- Inability to engage in physical activity (defined as walking two city blocks without stopping)
- Have diabetes or a history of bariatric surgery
- Current medical or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the program (i.e., bulimia nervosa, substance abuse disorder, psychosis, bipolar I disorder, and/or any condition prohibiting physical activity)
- Are pregnant or planning to become pregnant in the next 2 years
- Recently began or changed the dose of a medication that can cause significant change in weight
Show all 10Show fewer
- Have experienced weight loss ≥ 5% in the previous 6 months
- Are planning to begin in the next 16 months, or are currently participating in, another weight loss treatment or psychotherapy for binge eating and/or weight loss
- Are engaging in compensatory vomiting, other severe compensatory behaviors, or more than 12 of any compensatory behaviors in the previous 3 months
- Are currently taking medication (e.g., Contrave, Alli, etc.) which is specifically intended for weight loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Aberrant Decision Making Prevent Success in Adolescent Behavioral Weight Loss Treatment?
This study evaluates the associations between baseline decision-making processes, engagement in problematic dietary practices, and post-intervention weight loss outcomes among adolescents. Results from the study will provide specific direction for what components should comprise future decision-making interventions for adolescents with overweight/obesity.
Read the detailed description
Adolescent overweight and obesity (AOB; i.e., a body mass index (BMI) greater than 85th percentile for age, height, and gender) affects 34.5% of adolescents. Over 80% of obese adolescents will become obese adults and experience increased risk of cardiovascular disease, type 2 diabetes, gallbladder disease, and some forms of cancer. Because of contraindications and hesitations to pursue psychopharmacology or bariatric surgery, behavioral interventions are the first-line treatment for AOB. Unfortunately, adolescent outcomes from pediatric behavioral obesity treatments are poor. In fact, the modal weight loss in behavioral interventions is less than a single BMI point, and many participants lose no weight at all. Outcomes in adolescents are worse than those found in younger children and adults. Notably, the vast majority of existing interventions tested in adolescents are designed for younger children, which may preclude an adolescent's success in these interventions. Successful behavioral AOB interventions may require augmentations that address developmental concerns unique to adolescence. For example, research has shown that, in contrast to younger children, many adolescents are making their own food decisions and are thus more likely to engage in problematic eating behaviors during treatment. As a necessary step towards developing specialized interventions for AOB, it is critical to understand the underlying mechanisms of continued engagement in problematic eating behaviors during AOB interventions.
Three types of problematic eating behaviors are strongly linked (cross-sectionally and longitudinally) with AOB. First, reward-driven overeating (i.e., frequently eating energy-dense foods) results in excess calorie intake, which, in turn, produces adiposity during childhood and adolescence. Second, loss-of-control eating (LOC; the experience of not being able to stop eating once started) is an exceptionally strong predictor of excess weight gain, i.e., an additional 2.4kg per year compared to peers without LOC. Third, rigid dietary restriction involves skipping meals and cutting out food groups for the purposes of weight regulation, but instead results in intense feelings of deprivation. As a result, rigid dietary restriction has the paradoxical effect of calorie overconsumption, excess weight gain, and poor outcomes from pediatric obesity treatment. Taken together, findings indicate that elucidating the drivers of these three problematic eating behaviors is critical to improving AOB treatment outcomes.
An aberrant decision-making framework represents an attractive paradigm for understanding the above-described problematic eating behaviors, especially given that they all run counter to adolescents' intentions and well-being. There are several aberrant decision-making processes endemic to the adolescent developmental period. Three of these processes in particular appear to be directly linked to the three problematic eating behaviors described above. To the extent that aberrant decision-making produces problematic eating behavior, aberrant decision-making can also be hypothesized to predict poor weight loss outcomes. Below, three aberrant decision-making processes and their links to problematic eating behavior are described.
Increased delay discounting. Delay discounting refers to the tendency to discount greater, later rewards in favor of smaller, sooner rewards. A combination of greater sensitivity to reward and slow development of self-regulatory neural processes contributes to especially high discounting rates in some adolescents. Relatively higher discounting rates may produce reward-driven eating, i.e., frequent consumption of energy-dense foods (e.g., high-fat, high sugar foods), while discounting the future reward (e.g., weight loss) that would be derived from forgoing immediate gratification. Indeed, a recent meta-analysis concluded that higher discounting rates were strongly cross-sectionally linked with AOB. Although behavioral weight loss programs discourage consumption of energy-dense foods, psychological strategies for how to prioritize long-term over short-term rewards are not provided. Thus, delay discounting likely contributes to continued reward-driven eating during treatment. However, no studies have tested whether delay discounting predicts reward-driven overeating (and its effect on weight) during AOB treatment.
Affect-driven impulsivity. Affect-driven impulsivity refers to a tendency to choose maladaptive behaviors geared towards the immediate cessation of a negative affective state, despite negative consequences. Affect-driven impulsivity likely drives continued LOC eating during treatment, precluding successful weight loss. Affect-driven impulsivity is a cross-sectional predictor of AOB, but it may be a particularly strong driver of LOC eating because compulsive eating serves the function of reducing distress. Although no studies have compared adolescents with and without LOC on affect-driven impulsivity, adolescents with LOC eating demonstrate overall higher levels of emotional reactivity and emotional eating. LOC eating resulting from affect-driven impulsivity may continue to occur during treatment because little treatment content focuses on skills for tolerating negative affect. Dr. Manasse's work demonstrates that increased affect-driven impulsivity predicts poor outcomes from adult binge eating treatment. However, no studies have examined whether affect-driven impulsivity predicts (1) engagement in LOC during treatment or (2) poor AOB treatment outcomes.
Perseverative decision-making. Perseverative decision-making is characterized by weakened ability to stop engagement in habitual behaviors despite changing contingencies. Highly perseverative decision-making may contribute to repeated engagement in rigid dietary restriction (i.e., setting rigid calorie goals, cutting out specific foods) that increase deprivation. This deprivation, in turn, leads to episodes of overeating that preclude successful caloric restriction. Those who show highly perseverative decision-making continue engaging in this rigid dietary restriction behavior despite the fact that it ultimately delivers the opposite of its intended effect. Indeed, perseverative decision-making and rigid dieting are associated with the presence of LOC eating, and perseveration is cross-sectionally associated with obesity in adolescence. Despite the established links between perseverative decision-making with unhealthy dieting and excess weight, no studies have examined whether perseverative decision-making underlies continued engagement in problematic dietary restriction during treatment and predicts poor outcomes.
To inform the development of tailored intervention approaches, the current study, funded by the National Institutes of Health, aims to elucidate the specific aberrant decision-making processes associated with three problematic eating behaviors and weight loss outcomes. Results from the study will provide specific direction for what components (e.g., strategies for tolerating emotional distress or promoting flexible thinking) should comprise a future decision-making intervention for AOB and for whom (e.g., those with LOC, those who engage in problematic restriction) certain components would be most relevant. Given that LOC eating is a robust predictor of excess weight gain but only 20-30% of those with AOB endorse LOC eating, the study team will oversample individuals with clinically significant LOC, i.e., the study will recruit a total of 80 adolescents (ages 14-18) with overweight/obesity, half of whom (n=40) endorse clinically significant (i.e., at least once weekly) LOC eating and the other half of whom (n=40) endorse subclinical LOC or no LOC. All participants will receive a 16-week group-based, remotely delivered behavioral weight loss intervention and complete a 6-month follow-up. Decision-making measures will be administered at baseline. Problematic eating behaviors and weight will be assessed at all time points.
- Being tested
- Weight loss treatment
- Medical subject headings
- Overweight, Obesity, Impulsive Behavior, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss treatmentBehavioural
Also called Lifestyle modification
The intervention will consist of group-based, weekly or biweekly weight loss coaching (75 minutes per session), which will occur via Zoom videoconferencing software. This intervention is designed to facilitate a 5-10% weight loss and engagement in up to 250 min/week of moderate-to-vigorous physical activity, which is the standard recommendation in lifestyle modification programs for adolescents. Participants will also be asked to download and utilize the smartphone app, Fitbit, to track eating behavior. Weight loss coaches will be experts in lifestyle modification who have graduate degrees in psychology or a related field. Participants will be given guidance on how to reduce your calorie intake (using a balanced deficit diet) and gradually increase your physical activity. Participants will learn to set goals for diet, weight, and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent-specific behavioral weight loss treatment | Experimental | Not described Receives: Behavioral: Weight loss treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of 95 percentile BMI
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start3 Feb 2021
- Primary completion15 Oct 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight AdolescentsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Manasse, Ph.D., Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848532
- Sponsor's protocol ID
- 2005007834
- Acronym
- REACH
- Status last verified
- Jun 2025
- First submitted
- 17 Mar 2021
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Aberrant Decision Making Prevent Success in Adolescent Behavioral Weight Loss Treatment?
- ClinicalTrials.gov ID
- NCT04848532
- Acronym / sponsor ID
- REACH / 2005007834
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Apr 2021 (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.
This study evaluates the associations between baseline decision-making processes, engagement in problematic dietary practices, and post-intervention weight loss outcomes among adolescents. Results from the study will provide specific direction for what components should comprise future decision-making interventions for adolescents with overweight/obesity.
Detailed description
Adolescent overweight and obesity (AOB; i.e., a body mass index (BMI) greater than 85th percentile for age, height, and gender) affects 34.5% of adolescents. Over 80% of obese adolescents will become obese adults and experience increased risk of cardiovascular disease, type 2 diabetes, gallbladder disease, and some forms of cancer. Because of contraindications and hesitations to pursue psychopharmacology or bariatric surgery, behavioral interventions are the first-line treatment for AOB. Unfortunately, adolescent outcomes from pediatric behavioral obesity treatments are poor. In fact, the modal weight loss in behavioral interventions is less than a single BMI point, and many participants lose no weight at all. Outcomes in adolescents are worse than those found in younger children and adults. Notably, the vast majority of existing interventions tested in adolescents are designed for younger children, which may preclude an adolescent's success in these interventions. Successful behavioral AOB interventions may require augmentations that address developmental concerns unique to adolescence. For example, research has shown that, in contrast to younger children, many adolescents are making their own food decisions and are thus more likely to engage in problematic eating behaviors during treatment. As a necessary step towards developing specialized interventions for AOB, it is critical to understand the underlying mechanisms of continued engagement in problematic eating behaviors during AOB interventions.
Three types of problematic eating behaviors are strongly linked (cross-sectionally and longitudinally) with AOB. First, reward-driven overeating (i.e., frequently eating energy-dense foods) results in excess calorie intake, which, in turn, produces adiposity during childhood and adolescence. Second, loss-of-control eating (LOC; the experience of not being able to stop eating once started) is an exceptionally strong predictor of excess weight gain, i.e., an additional 2.4kg per year compared to peers without LOC. Third, rigid dietary restriction involves skipping meals and cutting out food groups for the purposes of weight regulation, but instead results in intense feelings of deprivation. As a result, rigid dietary restriction has the paradoxical effect of calorie overconsumption, excess weight gain, and poor outcomes from pediatric obesity treatment. Taken together, findings indicate that elucidating the drivers of these three problematic eating behaviors is critical to improving AOB treatment outcomes.
An aberrant decision-making framework represents an attractive paradigm for understanding the above-described problematic eating behaviors, especially given that they all run counter to adolescents' intentions and well-being. There are several aberrant decision-making processes endemic to the adolescent developmental period. Three of these processes in particular appear to be directly linked to the three problematic eating behaviors described above. To the extent that aberrant decision-making produces problematic eating behavior, aberrant decision-making can also be hypothesized to predict poor weight loss outcomes. Below, three aberrant decision-making processes and their links to problematic eating behavior are described.
Increased delay discounting. Delay discounting refers to the tendency to discount greater, later rewards in favor of smaller, sooner rewards. A combination of greater sensitivity to reward and slow development of self-regulatory neural processes contributes to especially high discounting rates in some adolescents. Relatively higher discounting rates may produce reward-driven eating, i.e., frequent consumption of energy-dense foods (e.g., high-fat, high sugar foods), while discounting the future reward (e.g., weight loss) that would be derived from forgoing immediate gratification. Indeed, a recent meta-analysis concluded that higher discounting rates were strongly cross-sectionally linked with AOB. Although behavioral weight loss programs discourage consumption of energy-dense foods, psychological strategies for how to prioritize long-term over short-term rewards are not provided. Thus, delay discounting likely contributes to continued reward-driven eating during treatment. However, no studies have tested whether delay discounting predicts reward-driven overeating (and its effect on weight) during AOB treatment.
Affect-driven impulsivity. Affect-driven impulsivity refers to a tendency to choose maladaptive behaviors geared towards the immediate cessation of a negative affective state, despite negative consequences. Affect-driven impulsivity likely drives continued LOC eating during treatment, precluding successful weight loss. Affect-driven impulsivity is a cross-sectional predictor of AOB, but it may be a particularly strong driver of LOC eating because compulsive eating serves the function of reducing distress. Although no studies have compared adolescents with and without LOC on affect-driven impulsivity, adolescents with LOC eating demonstrate overall higher levels of emotional reactivity and emotional eating. LOC eating resulting from affect-driven impulsivity may continue to occur during treatment because little treatment content focuses on skills for tolerating negative affect. Dr. Manasse's work demonstrates that increased affect-driven impulsivity predicts poor outcomes from adult binge eating treatment. However, no studies have examined whether affect-driven impulsivity predicts (1) engagement in LOC during treatment or (2) poor AOB treatment outcomes.
Perseverative decision-making. Perseverative decision-making is characterized by weakened ability to stop engagement in habitual behaviors despite changing contingencies. Highly perseverative decision-making may contribute to repeated engagement in rigid dietary restriction (i.e., setting rigid calorie goals, cutting out specific foods) that increase deprivation. This deprivation, in turn, leads to episodes of overeating that preclude successful caloric restriction. Those who show highly perseverative decision-making continue engaging in this rigid dietary restriction behavior despite the fact that it ultimately delivers the opposite of its intended effect. Indeed, perseverative decision-making and rigid dieting are associated with the presence of LOC eating, and perseveration is cross-sectionally associated with obesity in adolescence. Despite the established links between perseverative decision-making with unhealthy dieting and excess weight, no studies have examined whether perseverative decision-making underlies continued engagement in problematic dietary restriction during treatment and predicts poor outcomes.
To inform the development of tailored intervention approaches, the current study, funded by the National Institutes of Health, aims to elucidate the specific aberrant decision-making processes associated with three problematic eating behaviors and weight loss outcomes. Results from the study will provide specific direction for what components (e.g., strategies for tolerating emotional distress or promoting flexible thinking) should comprise a future decision-making intervention for AOB and for whom (e.g., those with LOC, those who engage in problematic restriction) certain components would be most relevant. Given that LOC eating is a robust predictor of excess weight gain but only 20-30% of those with AOB endorse LOC eating, the study team will oversample individuals with clinically significant LOC, i.e., the study will recruit a total of 80 adolescents (ages 14-18) with overweight/obesity, half of whom (n=40) endorse clinically significant (i.e., at least once weekly) LOC eating and the other half of whom (n=40) endorse subclinical LOC or no LOC. All participants will receive a 16-week group-based, remotely delivered behavioral weight loss intervention and complete a 6-month follow-up. Decision-making measures will be administered at baseline. Problematic eating behaviors and weight will be assessed at all time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent-specific behavioral weight loss treatment | Experimental | Behavioral: Weight loss treatment |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Are between 14 and 18 years of age
- Have a BMI between the 85th and 99th percentiles for sex and age as determined by the CDC growth charts
- Are currently living at home with a parent or guardian
- Have at least one parent or guardian who is willing to participate in the study
- Are willing to complete baseline assessment tasks
Key exclusion criteria (10 listed)
- Acute suicide risk
- Inability to engage in physical activity (defined as walking two city blocks without stopping)
- Have diabetes or a history of bariatric surgery
- Current medical or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the program (i.e., bulimia nervosa, substance abuse disorder, psychosis, bipolar I disorder, and/or any condition prohibiting physical activity)
- Are pregnant or planning to become pregnant in the next 2 years
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 |
|---|---|---|
| Weight loss treatmentAlso: Lifestyle modificationThe intervention will consist of group-based, weekly or biweekly weight loss coaching (75 minutes per session), which will occur via Zoom videoconferencing software. This intervention is designed to facilitate a 5-10% weight loss and engagement in up to 250 min/week of moderate-to-vigorous physical activity, which is the standard recommendation in lifestyle modification programs for adolescents. Participants will also be asked to download and utilize the smartphone app, Fitbit, to track eating behavior. Weight loss coaches will be experts in lifestyle modification who have graduate degrees in psychology or a related field. Participants will be given guidance on how to reduce your calorie intake (using a balanced deficit diet) and gradually increase your physical activity. Participants will learn to set goals for diet, weight, and physical activity. | Behavioural | Adolescent-specific behavioral weight loss treatment |
Primary outcome
Percent of 95 percentile BMI
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Overweight Adolescents
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
Not yet recruitingPhase 2
Supplementation of Gut-brain Axis (GLP-1)-Activating Carbohydrates for Increasing Satiety in Adolescents With Obesity
Obesity & Overweight
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. This study is not recruiting at the moment.
Stephanie Manasse, Ph.D. 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 Weight loss treatment in people with Overweight Adolescents and Overweight or Obesity, run by Drexel University 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 13 Jun 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of 95 percentile BMI (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.