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Behavioural Intervention

Extended Care Interventions for Weight Loss Maintenance (OPT-X Trial)

Birmingham, AL
N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years
Be older than 18 years old
Must not have
Weight loss >10 pounds in past 6 months (other than postpartum)
History of type 1 diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find the best way to help people maintain weight loss after losing weight. Participants will go through a 16-week weight loss program and those who lose at least 5% of their

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Who is the study for?
This trial is for individuals who have successfully lost at least 5% of their body weight and are looking to maintain that weight loss. It's ideal for those interested in trying different strategies, such as limiting food variety, home-based exercises, buddy support systems, or learning coping skills through workshops.Check my eligibility
What is being tested?
The study tests combinations of four methods: eating fewer types of high-calorie foods (RFV), strength-building workouts at home (HBRT), getting support from a trained friend (BTS), and attending workshops on handling emotions related to weight control (ACT). Participants will be randomly assigned a mix of these methods over 12 months to find the most effective strategy.See study design
What are the potential side effects?
Potential side effects may include physical strain or injury from resistance training exercises. Emotional discomfort could arise during ACT workshops when discussing weight-related thoughts and feelings. Dietary changes might lead to nutritional imbalances if not properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have lost more than 10 pounds in the last 6 months, not due to childbirth.
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I have a history of type 1 diabetes.
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I have a chronic lung disease that affects my physical activity.
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I have severe heart failure.
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I am willing and able to give informed consent, understand English, and accept random assignment.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in weight from time of randomization to 12 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

16Treatment groups
Experimental Treatment
Active Control
Group I: Package 16: Four WLM Components: RFV+HBRT+BTS+ACTExperimental Treatment4 Interventions
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, Buddy Training and Support, and ACT Workshops.
Group II: Package 10: Two WLM Components - RFV+BTSActive Control2 Interventions
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Buddy Training and Support
Group III: Package 11: Two WLM Components - RFV+HBRTActive Control2 Interventions
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Home-based Resistance Training.
Group IV: Package 1: No WLM ComponentsActive Control1 Intervention
Participants will receive education and support for weight loss maintenance only.
Group V: Package 2: One WLM Component - BTSActive Control1 Intervention
Participants will receive education and support for weight loss maintenance and Buddy Training and Support.
Group VI: Package 4: Two WLM Components - HBRT+BTSActive Control2 Interventions
Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and Buddy Training and Support.
Group VII: Package 15: Three WLM Components - RFV+HBRT+ACTActive Control3 Interventions
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and ACT Workshops.
Group VIII: Package 6: Two WLM Components - BTS+ACTActive Control2 Interventions
Participants will receive education and support for weight loss maintenance as well as Buddy Training and Support and ACT Workshops.
Group IX: Package 5: One WLM Component - ACTActive Control1 Intervention
Participants will receive education and support for weight loss maintenance as well as Acceptance and Commitment (ACT) Workshops.
Group X: Package 12: Three WLM Components - RFV+HBRT+BTSActive Control3 Interventions
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and Buddy Training and Support.
Group XI: Package 13: Two WLM Components - RFV+ACTActive Control2 Interventions
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and ACT Workshops.
Group XII: Package 14: Three WLM Components - RFV+BTS+ACTActive Control3 Interventions
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Buddy Training and Support, and ACT Workshops.
Group XIII: Package 3: One WLM Component - HBRTActive Control1 Intervention
Participants will receive education and support for weight loss maintenance and Home-based Resistance Training
Group XIV: Package 8: Three WLM Components - HBRT+BTS+ACTActive Control3 Interventions
Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training, Buddy Training and Support, and ACT Workshops.
Group XV: Package 9: One WLM Component - RFVActive Control1 Intervention
Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety.
Group XVI: Package 7: Two WLM Components - HBRT+ACTActive Control2 Interventions
Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and ACT Workshops.

Find a Location

Closest Location:University of Alabama at Birmingham· Birmingham, AL· 493 miles
Image of University of Alabama at Birmingham in Birmingham, United States.Image of University of Alabama at Birmingham in Birmingham, United States.Image of University of Alabama at Birmingham in Birmingham, United States.

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,674 Previous Clinical Trials
2,456,724 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,504 Previous Clinical Trials
4,363,881 Total Patients Enrolled
~363 spots leftby Nov 2028
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