Healthy Lifestyle Intervention for Obesity in Teens

(LIFT Trial)

Overseen By Rashon Braxton

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Not medically referred, refuses participation

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

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if combining weight-loss surgery with healthy living advice works well for teenagers who need extra help losing weight.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the Healthy Lifestyle Intervention for Obesity in Teens safe?

The studies reviewed did not report any safety concerns for healthy lifestyle interventions in adolescents, suggesting they are generally safe for human participants. ^{1 2 3 4 5}

How is the Healthy Lifestyle Behavioral Intervention treatment for obesity in teens different from other treatments?

The Healthy Lifestyle Behavioral Intervention is unique because it focuses on promoting a healthy lifestyle rather than just weight loss, emphasizing both physical and mental well-being. It is tailored to adolescent preferences, including having relatable instructors and engaging activities, which may improve its effectiveness and appeal to teens. ^{1 4 6 7 8}

What data supports the effectiveness of the Healthy Lifestyle Behavioral Intervention treatment for obesity in teens?

Research shows that lifestyle interventions, which include nutrition education, behavior therapy, and exercise, are effective for weight loss in children and teens. These interventions have been proven to improve health factors like cardiovascular risk and quality of life, especially when parents are involved. ^{9 10 11 12 13}

Who Is on the Research Team?

Sarah E Messiah, Ph.D., MPH

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for teens with severe obesity, defined as having a BMI over 35 with related health issues like high blood pressure or cholesterol, or a BMI over 40. They must be considered candidates for bariatric surgery according to NIH guidelines and have received psychological clearance.

Inclusion Criteria

I am eligible for weight loss surgery based on my BMI and health conditions.

I am eligible for weight loss surgery based on my BMI and health conditions.

I have been cleared by a psychologist for surgery.

Exclusion Criteria

I do not want to participate in the study.

I have not been referred for weight loss surgery by a doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery

Participants undergo pre-surgery assessments and preparation

1 month

Surgery

Participants undergo metabolic and bariatric surgery

Post-surgery Treatment

Participants receive a healthy lifestyle behavioral intervention supported by the clinical team

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Lifestyle Behavioral Intervention

Trial Overview The study tests a healthy lifestyle behavioral intervention supported by Metabolic and Bariatric Surgery (MBS) teams. It aims to see if this approach is feasible, acceptable, and effective in helping obese adolescents and their families make positive changes.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Both short-stay (2 months) and long-stay (6 months) intensive lifestyle treatments for severely obese children resulted in significant reductions in SDS-BMI after one year, indicating that both approaches are effective.

There were no significant differences in outcomes between the two treatment durations, suggesting that the shorter treatment may be preferable due to its lower burden on children and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year effects of two intensive inpatient treatments for severely obese children and adolescents. Makkes, S., Renders, CM., Bosmans, JE., et al.[2023]

In a study involving 686 obese children aged 7-13, inpatient lifestyle treatment led to a significant short-term decrease in BMI-SDS, but long-term weight maintenance results were similar regardless of whether parents received additional cognitive-behavioral training or just written information.

Both groups showed improvements in quality of life, healthy food intake, and exercise, indicating that while inpatient treatment is effective, the inclusion of parent training did not enhance long-term outcomes for weight maintenance or psychosocial well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training. Warschburger, P., Kroeller, K., Haerting, J., et al.[2019]

In a study of 568 children and adolescents with severe obesity, 73% attended a one-year follow-up, showing a moderate mean reduction in key weight measures, including BMI and waist circumference, indicating that lifestyle interventions can be effective in this population.

About 65% of participants achieved a reduction in their percentage overweight, with 17% moving from severe obesity to obesity, highlighting that while the interventions had positive outcomes, individual responses varied significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention for children and adolescents with severe obesity - results after one year. Skodvin, VA., Lekhal, S., Kommedal, KG., et al.[2021]

The Coaching on Lifestyle programme (CooL) effectively helped adults achieve sustained improvements in motivation, lifestyle behaviors, quality of life, and weight over an 18-month period.

While adults showed significant positive changes, the program had mixed results for children and their parents, indicating that different strategies may be needed to engage younger participants effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. van Rinsum, C., Gerards, S., Rutten, G., et al.[2019]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

One-year effects of two intensive inpatient treatments for severely obese children and adolescents. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Long-term effect of lifestyle intervention on adiposity, metabolic parameters, inflammation and physical fitness in obese children: a randomized controlled trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training. [2019]

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

Long-term follow-up of obesity in adolescents. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of lifestyle intervention in overweight children. [2019]

6. Norway pubmed.ncbi.nlm.nih.gov

Lifestyle intervention for children and adolescents with severe obesity - results after one year. [2021]

7. India pubmed.ncbi.nlm.nih.gov

Evaluation of a group family-based intervention programme for adolescent obesity: the LITE randomised controlled pilot trial. [2023]

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

A Family-Based Healthy Lifestyle Intervention: Crossover Effects on Substance Use and Sexual Risk Behaviors. [2022]

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

Behavioral Weight Loss Intervention Preferences of Adolescents with Overweight/Obesity. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Coaching on Lifestyle (CooL) Intervention for Overweight and Obesity: A Longitudinal Study into Participants' Lifestyle Changes. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Extremely obese children respond better than extremely obese adolescents to lifestyle interventions. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. [2022]

13. England pubmed.ncbi.nlm.nih.gov

End-user perspectives to inform policy and program decisions: a qualitative and quantitative content analysis of lifestyle treatment recommendations by adolescents with obesity. [2020]