Physical Activity Choices Everyday (PACE)

University of Connecticut

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Weight Loss Maintenance + Healthy Thinking; Behavioral: Weight Loss Maintenance Treatment + Future Thinking

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03824769

R21NR018359 (U.S. NIH Grant/Contract)

H18-153

Details and patient eligibility

About

This study aims to test two strategies for weight loss maintenance. It involves two phases, a weight loss phase and a maintenance phase. During Phase I (the weight loss phase), participants will receive a 16-week, Web-based behavioral weight loss program that involves access to weekly weight loss information and weekly personalized feedback on diet, activity, and weight loss goals. Individuals who lose at least 5% of their initial body weight during this program, will be invited to participate in Phase II. During Phase II, two 4-month treatments for weight loss maintenance will be tested. At the beginning of Phase II, participants will be randomly assigned to one of the two maintenance programs: (1) a behavioral maintenance program that involves in-person group meetings plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral maintenance program that involves in-person group meetings plus daily exercises in which descriptions of positive future events are reviewed. Throughout the study, participants will complete assessments that examine the effects of the interventions on delay discounting, physical activity, weight, and other important health and psychosocial outcomes.

Enrollment: 160 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18-70
• Body Mass Index between 30-50
• English Speaking
• Have a smartphone that can be used for study activities

Exclusion criteria

• Report being unable to walk 2 blocks without stopping
• Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
• Are pregnant or plan to become pregnant within 1 year
• Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
• Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
• History of or current traumatic brain injury, dementia or Alzheimer's disease; a history of Multiple Sclerosis, or other neurological disorders
• Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
• Have no Internet access or unwilling to use personal smartphone for study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Behavioral Weight Loss Maintenance + Healthy Thinking

Active Comparator group

Description:

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.

Treatment:

Behavioral: Weight Loss Maintenance + Healthy Thinking

Behavioral Weight Loss Maintenance Treatment + Future Thinking

Experimental group

Description:

Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.

Treatment:

Behavioral: Weight Loss Maintenance Treatment + Future Thinking