Physical Activity Choices Everyday- A Pilot Study (PACE)

Decisions About Exercise During Weight Loss: Pilot Study

This study aims to test two strategies for weight loss. Participants will be randomly assigned to one of the two 4-week weight loss programs: (1) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake 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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Behavioral Weight Loss + Healthy Thinking; Behavioral: Behavioral Weight Loss + Future Thinking

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06103
      • UConn Weight Management Research Laboratory

Participation Criteria

Eligibility Criteria

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

Description

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 2 months
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Behavioral Weight Loss + Healthy Thinking; Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss 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: Behavioral Weight Loss + Healthy Thinking; Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills.
Experimental: Behavioral Weight Loss + Future Thinking; Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss 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: Behavioral Weight Loss + Future Thinking; Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity	Change in minutes of moderate to vigorous physical activity measured via a waist worn accelerometer during 7 day time periods.	baseline and week 7
Delay Discounting	Change in delay discounting measured using a choice task.	baseline and week 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight change from baseline to post treatment	4 weeks

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Institute of Nursing Research (NINR); University of Southern California; University at Buffalo; Kent State University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): May 17, 2019
• Study Completion (Actual): May 17, 2019

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 31, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: H19-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No