Physical Activity Choices Everyday (PACE)

December 8, 2023 updated by: Amy Gorin, University of Connecticut

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry
Time Frame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
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)
Delay Discounting (Adjusting Amount Task)
Time Frame: Phase II baseline to 1 month, 2 months and 4 months (end of treatment)
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)
Delay Discounting (Monetary Choice Questionnaire)
Time Frame: Phase II baseline to 2 months and 4 months (end of treatment)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 4 months
Weight change from end of Phase 1 weight loss program to end of Phase II maintenance program
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Connecticut

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)
University of Southern California
University at Buffalo
Kent State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy Gorin, PhD, University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H18-153
  • R21NR018359 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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