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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
See study description for details. All participants will receive all intervention elements, with allocation varying randomly across time using procedures appropriate for system identification.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: Intervention Targeting Stress and Emotion Regulation
    This intervention involves learning and practicing relaxation exercises and setting aside time for pleasurable activities.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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.

Recruiting Locations

Miriam Hospital Weight Control and Diabetes Resarch Center
Providence, Rhode Island 02903
Contact:
Sharon O'Toole, M.A.T.
401-793-8992
sotoole@lifespan.org

More Details

Status
Recruiting
Sponsor
The Miriam Hospital

Study Contact

Sharon O'Toole, M.A.T.
401 793-8992
sotoole@lifespan.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.