Cognitive Behavioural Therapy for Adolescent Obesity

Recruiting at 2 trial locations

Overseen By Jon McGavock, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Obesity medications, Steroids, Antipsychotics

Disqualifiers: Orthopedic injury, Chronic illness, Alcoholism, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Dialectical Behavioral Therapy (DBT), combined with lifestyle changes, can improve quality of life and manage weight in teens at risk for type 2 diabetes. Participants will join one of three groups: receiving both DBT and lifestyle sessions, lifestyle sessions alone, or no intervention. Teens aged 14-17 with mild to moderate depression and a high BMI (a measure of body fat based on height and weight) may be suitable candidates. As an unphased study, this trial provides a unique opportunity to contribute to innovative research that could enhance future treatments for teens.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are being treated with medication for obesity, taking steroids, or being treated with atypical antipsychotics.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Dialectical Behavioral Therapy (DBT) is generally safe for teenagers. Studies indicate it helps with mental and behavioral health issues without major side effects. For instance, one study found that DBT improved emotional control in teens with obesity without causing harm.

Lifestyle changes, such as improving diet and exercise, are also safe for young people. These changes can help reduce body weight and enhance quality of life. Research shows these programs don't lead to serious health problems.

Both treatments are well-tolerated and have been used successfully in similar situations. Therefore, participating in a trial with these therapies should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for adolescent obesity because they incorporate Dialectical Behavioral Therapy (DBT), which is not typically part of current obesity treatments. DBT is unique as it focuses on emotional regulation and coping strategies, potentially helping adolescents manage the psychological aspects of weight management. Additionally, the combination of DBT with lifestyle modifications offers a holistic approach that could address both behavioral and emotional components of obesity. Unlike standard treatments that might focus solely on diet and exercise, this method aims to create sustainable behavioral changes by addressing underlying emotional triggers.

What evidence suggests that this trial's treatments could be effective for adolescent obesity?

Research has shown that Dialectical Behavioral Therapy (DBT), one of the treatments in this trial, can help teenagers manage their weight and emotions. In one study, participants lost an average of 3 kg after treatment and maintained the weight loss over time. Another study found that DBT improved emotional control and reduced symptoms of depression, often linked to being overweight.

For lifestyle changes, another treatment arm in this trial, studies have shown that combining healthy eating, exercise, and behavior changes can effectively lower BMI, a measure of body fat, in teenagers. These methods focus on building healthy habits rather than just losing weight. Overall, both DBT and lifestyle changes appear promising for helping young people manage their weight and improve their quality of life, especially those at risk for type 2 diabetes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adolescents aged 14-17 with obesity, willing to follow study procedures and showing mild-moderate depression. They must not be on certain medications like atypical antipsychotics or steroids, have multiple health issues, a history of self-harm in the last year, currently in psychotherapy/DBT, or have had recent weight loss treatments.

Inclusion Criteria

Your body mass index (BMI) is significantly higher than average for your age and gender.

Willing and able to comply with study procedures

I have mild to moderate depression.

Exclusion Criteria

I am currently on medication for mental health using atypical antipsychotics.

I have a physical condition that stops me from doing certain activities.

I am unable or unwilling to agree to participate in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive weekly group-based sessions in one of three intervention arms: lifestyle + DBT, lifestyle alone, or control for 16 weeks

16 weeks

Weekly sessions

Follow-up

Participants are monitored for retention and follow-up measurements at 16 and 32 weeks

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dialectical Behavioral Therapy (DBT)
• Lifestyle

Trial Overview The study tests if Dialectical Behavioral Therapy (DBT), which includes mindfulness and stress coping strategies, can improve life quality and help manage weight in youth at risk for type 2 diabetes. Participants will join one of three groups: lifestyle changes plus DBT sessions, just lifestyle changes, or a control group.

How Is the Trial Designed?

Group I: Lifestyle alone Experimental Treatment 1 Intervention

Participants will receive 2 lifestyle sessions per week, 90 minutes each for 16 weeks.

Group II: DBT + lifestyle Experimental Treatment 2 Interventions

Participants will receive 90 minutes of dialectical behavioral therapy and 90 minutes of lifestyle sessions each week for 16 weeks.

Group III: Control Active Control 1 Intervention

Participants will be included in baseline, endpoint and follow up measurements, but will receive no form of intervention.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Diabetes Canada

Collaborator

Trials

13

Recruited

1,200+

Children's Hospital Research Institute of Manitoba (CHRIM)

Collaborator

Trials

2

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10586458/

Evidence Base Update on Behavioral Treatments for ... This review provides an update to a previous Evidence Base Update addressing behavioral treatments for overweight and obesity in children and adolescents.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1499267124002363

Dialectal Behaviour Therapy and Lifestyle Change to ... Emotion regulation scores improved in all participants, while 5 of 6 participants improved depressive symptom scores. Measures of adiposity improved in the ...

3. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-021-00461-1

A systematic review of cognitive behavior therapy and ... This review concludes that CBT and DBT-informed interventions have good feasibility and acceptability for adolescent eating disorders, with ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005789422000119

An Open Trial Examining Dialectical Behavior Therapy ... On average, participants lost 3.00 kg at posttreatment, which was maintained at follow-up. Intent-to-treat analyses showed improvements in key outcome variables ...

5. researchgate.net researchgate.net/publication/350073771_Efficacy_of_Dialectical_Behavior_Therapy_on_Decreasing_Weight_in_Obese_Women_with_Emotional_and_Behavioral_Disorders_A_Quasi_Experimental_Study

Efficacy of Dialectical Behavior Therapy on Decreasing ... Efficacy of Dialectical Behavior Therapy on Decreasing Weight in Obese Women with Emotional and Behavioral Disorders: A Quasi Experimental Study. March 2021 ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722924000269

Clinical Applications of Dialectical Behavior Therapy With ... Dialectical behavior therapy balances both change and acceptance-based strategies and may be helpful for pediatric patients, families, and medical providers.

7. journal.razavihospital.ir journal.razavihospital.ir/article_118474_1fe7b873da0e91f88608acf6a79924d7.pdf

Effectiveness of Dialectical Behavior Therapy on Emotion ... This study aimed to determine the effectiveness of dialectical behavior therapy on BMI, food craving, and emotion regulation in adolescent girls with obesity.

8. link.springer.com link.springer.com/article/10.1007/s40519-023-01612-w

A 12-month study of dialectical behavioral therapy for ... The first main finding of the study was the significant improvement in all outcome measures at post-treatment compared to those at pre-treatment ...

9. researchgate.net researchgate.net/publication/317076428_Dialectical_Behavior_Therapy_in_Adolescent_Residential_Treatment_Outcomes_and_Effectiveness

Dialectical Behavior Therapy in Adolescent Residential ... Outcome data for DBT-A have demonstrated the effectiveness of the intervention in treating various mental and behavioral health conditions in adolescents ...