Control Systems Engineering for Weight Loss Maintenance

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
The Miriam Hospital
Study ID
NCT06244888
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Intervention Targeting Stress and Emotion Regulation — BEHAVIORAL
    This intervention involves learning and practicing relaxation exercises and setting aside time for pleasurable activities.
  • Intervention Targeting Motivation and Self-efficacy for Weight Management — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Jan 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Weight change [ Time Frame: Every day during the 52-week system identification experiment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Miriam Hospital Weight Control and Diabetes Resarch CenterProvidenceRhode Island02903
Sharon O'Toole, M.A.T.
[email protected]
401-793-8992

Find similar trials in Providence, RI

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Miriam Hospital Weight Control and Diabetes Resarch Center· Providence, RI

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