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Behavioural Intervention

Behavioral Interventions for Weight Loss

Phase 2
Recruiting
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
English language fluent and literate at the 6th grade level
Able to walk 2 city blocks without stopping
Must not have
Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
Currently taking weight loss medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every day during the 52-week system identification experiment
Awards & highlights

Summary

This trial aims to use a mathematical model based on control systems engineering to predict weight change during weight loss maintenance. Participants will undergo a 6-month weight loss program and those who lose at least 3

Who is the study for?
This trial is for individuals who are obese and have successfully lost at least 3% of their initial body weight. Participants should be willing to use a smartphone daily for surveys and passive sensing over a period of 12 months.
What is being tested?
The study tests interventions aimed at maintaining weight loss by focusing on physical activity, sleep, stress, emotion regulation, motivation, self-efficacy, and eating habits. It uses control systems engineering to predict when someone might regain weight.
What are the potential side effects?
Since the interventions involve behavioral changes rather than medication or surgery, side effects may include psychological discomfort from lifestyle adjustments or stress from adherence to new routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can read and speak English at a 6th grade level or higher.
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I can walk 2 city blocks without needing to stop.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had heart issues, chest pain, or fainting in the last year.
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I am currently on medication for weight loss.
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I have lost 5% or more of my body weight in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every day during the 52-week system identification experiment
This trial's timeline: 3 weeks for screening, Varies for treatment, and every day during the 52-week system identification experiment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weight change
Secondary study objectives
Affect
Dietary Lapse
Dysregulated Eating
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: System IdentificationExperimental Treatment4 Interventions
All participants who lose at least 3% of their initial body weight will be asked to participate in a system identification experiment every day for 52 weeks.

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Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,410 Previous Clinical Trials
4,324,711 Total Patients Enrolled
460 Trials studying Obesity
589,550 Patients Enrolled for Obesity
The Miriam HospitalLead Sponsor
243 Previous Clinical Trials
37,527 Total Patients Enrolled
76 Trials studying Obesity
15,096 Patients Enrolled for Obesity
~120 spots leftby Dec 2027
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