Physical Activity Choices Everyday (PACE)

• ClinicalTrials.gov Identifier: NCT03824769
• Recruitment Status: Completed
• First Posted: January 31, 2019
• Last Update Posted: September 30, 2021
• Sponsor: University of Connecticut
• Collaborators: National Institute of Nursing Research (NINR); University at Buffalo; Kent State University; University of Southern California
• Information provided by (Responsible Party): Amy Gorin, University of Connecticut

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: Weight Loss Maintenance + Healthy Thinking; Behavioral: Weight Loss Maintenance Treatment + Future Thinking	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Is Long-term Maintenance Worth the Wait? Using Real Time Data Capture to Examine Delayed Discounting as a Putative Target of Physical Activity Adherence in Weight Loss Maintenance Interventions
• Actual Study Start Date: March 11, 2019
• Actual Primary Completion Date: May 3, 2021
• Actual Study Completion Date: May 3, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Behavioral Weight Loss Maintenance + Healthy Thinking; 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.	Behavioral: Weight Loss Maintenance + Healthy Thinking; 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.
Experimental: Behavioral Weight Loss Maintenance Treatment + Future Thinking; 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.	Behavioral: Weight Loss Maintenance Treatment + Future Thinking; 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.

Outcome Measures

Primary Outcome Measures :

1. Physical Activity [ Time Frame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment) ]
   Change in minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II maintenance program.
2. Delay Discounting [ Time Frame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment) ]
   Change in delay discounting measured using a choice task during the Phase II maintenance program

Secondary Outcome Measures :

1. Weight [ Time Frame: 4 months ]
   Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Connecticut

UConn Weight Management Research Laboratory

Hartford, Connecticut, United States, 06103

Sponsors and Collaborators

University of Connecticut

National Institute of Nursing Research (NINR)

University at Buffalo

Kent State University

University of Southern California

Investigators

• Principal Investigator: Amy Gorin, PhD; University of Connecticut

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leahey TM, Gorin AA, Wyckoff E, Denmat Z, O'Connor K, Field C, Dunton GF, Gunstad J, Huedo-Medina TB, Gilder C. Episodic future thinking, delay discounting, and exercise during weight loss maintenance: The PACE trial. Health Psychol. 2020 Sep;39(9):796-805. doi: 10.1037/hea0000860.

• Responsible Party: Amy Gorin, Director, Institute for Collaboration on Health, Intervention, and Policy Professor, Psychological Sciences, University of Connecticut
• ClinicalTrials.gov Identifier: NCT03824769
• Other Study ID Numbers: H18-153; R21NR018359 ( U.S. NIH Grant/Contract )
• First Posted: January 31, 2019
• Last Update Posted: September 30, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amy Gorin, University of Connecticut:

Weight Loss Maintenance