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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06244888
Other study ID # 422620
Secondary ID 1R01DK137423
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 26, 2024
Est. completion date December 31, 2027

Study information

Verified date January 2024
Source The Miriam Hospital
Contact Sharon O'Toole, M.A.T.
Phone 401 793-8992
Email sotoole@lifespan.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project capitalizes on principles of control systems engineering to build a dynamical model that predicts weight change during weight loss maintenance using behavioral, psychosocial, and environmental indicators evaluated in a system identification experiment. A 6-month behavioral obesity treatment will be administered to produce weight loss. Participants losing at least 3% of initial body weight will be followed for an additional 12 months via daily smartphone surveys that incorporates passive sensing to objectively monitor key behaviors. Survey data pertaining to behavioral, psychosocial, and environmental indicators will be used to develop a controller algorithm that can predict when an individual is entering a heightened period of risk for regain and why risk is elevated. Interventions targeting key risk indicators will be randomly administered during the system ID experiment. Survey and passive sensing data documenting the effects of the interventions will likewise drive development of the controller algorithm, allowing it to determine which interventions are most likely to counter risk of regain.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - English language fluent and literate at the 6th grade level - Body mass index (BMI) between 25 and 50 kg/m-squared - Able to walk 2 city blocks without stopping - Owns a smartphone Exclusion Criteria: - 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 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
United States Miriam Hospital Weight Control and Diabetes Resarch Center Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
The Miriam Hospital National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight change This will be measured throughout the system identification experiment using a consumer scale with internet connectivity. Every day during the 52-week system identification experiment
Secondary Intervention engagement Intervention engagement will be measured by the smartphone application that delivers intervention. Engagement is defined as the count of clicks to open intervention resources. Every day during the 52-week system identification experiment
Secondary Weight Locus of Control Mean scale score of questionnaire items adapted from the Multidimensional Health Locus of Control scale for smartphone administration. Every day during the 52-week system identification experiment
Secondary Perceived Benefit of Weight Control Mean scale score of questionnaire items adapted from the Beliefs about Dietary Compliance Scale and the Exercise Benefits/Barriers scale for smartphone administration. Every day during the 52-week system identification experiment
Secondary Weight Control Strategies Intentions and Implementation Mean scale score of questionnaire items adapted from the Weight Control Strategies scale for smartphone administration. Every day during the 52-week system identification experiment
Secondary Hunger and Cravings Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration. Every day during the 52-week system identification experiment
Secondary Affect Mean scale score of questionnaire items adapted from the Profile of Mood States and Positive and Negative Affect States for smartphone administration. Every day during the 52-week system identification experiment
Secondary Stress Mean scale score of questionnaire items adapted from Cohen's Stress Scale for smartphone administration. Every day during the 52-week system identification experiment
Secondary Self-efficacy Mean scale score of questionnaire items adapted from the short-form Weight Efficacy Lifestyle Questionnaire for smartphone administration. Every day during the 52-week system identification experiment
Secondary Sleep Wrist-worn accelerometer-measured sleep timing, duration & quality. Every day during the 52-week system identification experiment
Secondary Social Support Mean scale score of questionnaire items adapted from the short-form Multidimensional Scale of Perceived Social Support for smartphone administration. Every day during the 52-week system identification experiment
Secondary Physical Activity Wrist-worn accelerometer-measured minutes per day of physical activity. Every day during the 52-week system identification experiment
Secondary Dysregulated Eating Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration. Every day during the 52-week system identification experiment
Secondary Dietary Lapse Count of self-reported instances of unintended eating, eating larger portions than one intended, and eating foods that one intended to avoid Every day during the 52-week system identification experiment
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