Control Systems Engineering for Weight Loss Maintenance
NCT ID: NCT06244888
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2024-02-26
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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System Identification
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.
Intervention Targeting Stress and Emotion Regulation
This intervention involves learning and practicing relaxation exercises and setting aside time for pleasurable activities.
Intervention Targeting Motivation and Self-efficacy for Weight Management
This intervention involves identifying values related to weight, lifestyle, and health; identifying barriers to value-consistent living; exploring the consequences of letting barriers drive behavior; and 4) setting goals that are small, specific, attainable, and values-consistent.
Intervention for Normalization of Eating
This intervention involves dietary self-monitoring with the goal of staying within a calorie goal ranging from 1,200 kcal/day to 1,800 kcal/day. Participants are also provided with meal planning tools and encouraged to addresses hunger and cravings by promoting feelings of satiety via consumption of foods that are high in volume but low in calories.
Intervention Targeting Physical Activity and Sleep
This simple intervention prompts participants at the start of the day to schedule up to 30 minutes of moderate-to-vigorous intensity physical activity; brisk walking is encouraged. Participants also set a bedtime and wake time and are encouraged to set a reminder alarm to ensure at least 8 hours of sleep.
Interventions
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Intervention Targeting Stress and Emotion Regulation
This intervention involves learning and practicing relaxation exercises and setting aside time for pleasurable activities.
Intervention Targeting Motivation and Self-efficacy for Weight Management
This intervention involves identifying values related to weight, lifestyle, and health; identifying barriers to value-consistent living; exploring the consequences of letting barriers drive behavior; and 4) setting goals that are small, specific, attainable, and values-consistent.
Intervention for Normalization of Eating
This intervention involves dietary self-monitoring with the goal of staying within a calorie goal ranging from 1,200 kcal/day to 1,800 kcal/day. Participants are also provided with meal planning tools and encouraged to addresses hunger and cravings by promoting feelings of satiety via consumption of foods that are high in volume but low in calories.
Intervention Targeting Physical Activity and Sleep
This simple intervention prompts participants at the start of the day to schedule up to 30 minutes of moderate-to-vigorous intensity physical activity; brisk walking is encouraged. Participants also set a bedtime and wake time and are encouraged to set a reminder alarm to ensure at least 8 hours of sleep.
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) between 25 and 50 kg/m-squared
* Able to walk 2 city blocks without stopping
* Owns a smartphone
Exclusion Criteria
* Currently participating in another weight loss program
* Currently taking weight loss medication
* Has lost ≥5% of body weight in the 6 months prior to enrolling
* Has been pregnant within the 6 months prior to enrolling
* Plans to become pregnant within 18 months of enrolling
* Any medical condition that would affect the safety of participating in unsupervised physical activity
* Any condition that would result in inability to follow the study protocol, including terminal illness and untreated major psychiatric illness
18 Years
70 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The Miriam Hospital
OTHER
Responsible Party
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Locations
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Miriam Hospital Weight Control and Diabetes Resarch Center
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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422620
Identifier Type: -
Identifier Source: org_study_id
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