Physical Activity Choices Everyday

Obesity Clinical Trial

— PACE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824769
• Other study ID #: H18-153
• Secondary ID: R21NR018359
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: May 3, 2021

Study information

• Verified date: December 2023
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UConn Weight Management Research Laboratory	Hartford	Connecticut

Sponsors (5)

Lead Sponsor	Collaborator
University of Connecticut	Kent State University, National Institute of Nursing Research (NINR), University at Buffalo, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry	Change in weekly minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during the Phase II maintenance program. At each assessment time point, participants were instructed to wear the accelerometer on their right waist during all waking hours for 7 days. Participants with a minimum of 600 min of valid daily wear time for at least 4 days were included in reported outcomes.	Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
Primary	Delay Discounting (Adjusting Amount Task)	Change in delay discounting measured using the Adjusting Amount task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The Adjusting Amount task identifies an individual's discount rate, which reflects how much they devalue future rewards. In the task, participants are presented with a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) monetary reward. Then, using a titration procedure, the delayed reward amount is adjusted based on the participant's choices to find the point at which they are indifferent between the two options (i.e., discounting rate). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.	Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
Primary	Delay Discounting (Monetary Choice Questionnaire)	Change in delay discounting measured using the Monetary Choice Questionnaire (MCQ) task during the Phase II maintenance program. Delay discounting refers to the decline in the present value of a reward with delay to its receipt. The MCQ identifies an individual's discount rate, which reflects how much they devalue future rewards. In the task, each question asks participants to make a choice between a smaller, immediate (hypothetical) monetary reward and a larger, delayed (hypothetical) reward. Unlike the Adjusting Amount task, each MCQ question includes different combinations of delay periods and reward amounts that are not influenced by previous responses (i.e., delay periods and reward amounts are static and the same for each participant). The discount rate is represented by "k". A higher "k" value means a steeper discount rate, indicating a greater preference for immediate rewards and a higher devaluation of future rewards.	Phase II baseline to 2 months and 4 months (end of treatment)
Secondary	Weight	Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program	4 months