Gaining Optimism After Weight Loss Surgery (GOALS) I (GOALS)

January 14, 2026 updated by: Emily Feig, Ph.D., Massachusetts General Hospital

Gaining Optimism After Weight Loss Surgery (GOALS) I: Proof-of-Concept Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery

This study examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (PP-MI) intervention for physical activity among patients who have recently undergone bariatric surgery.

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.

Detailed Description

This study will test a positive psychology-motivational interviewing (PP-MI) intervention for physical activity promotion in patients who have had bariatric surgery within the past 6-12 months. The investigators will enroll 12 participants. Study participation includes attending three study visits (two at baseline, one after the intervention) and receiving a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a Fitbit activity tracker. Primary outcomes are feasibility and acceptability of the intervention and study procedures. Secondary outcomes include pre-post changes in physical activity and other psychological, behavioral, and physiological outcomes.

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.
12

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult (age 18+)
  • History of bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two academic medical centers within the past 6-12 months
  • Interest in increasing physical activity
  • Low physical activity, defined as <200 minutes/week self-reported moderate- to-vigorous physical activity
  • Access to telephone for study sessions
  • Able to read and speak English

Exclusion Criteria:

  • Cognitive deficits precluding participation or informed consent
  • Illness likely to lead to death in the next 6 months
  • Inability to be physically active (e.g., severe arthritis)
  • Participation in another program targeting physical activity besides their standard offerings at the surgery center.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Experimental: Positive Psychology-Motivational Interviewing Intervention
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
Behavioral: Positive Psychology-Motivational Interviewing Intervention
Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.

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
Number of Intervention Sessions Completed
Time Frame: 10 weeks
Feasibility will be measured by examining the number of completed intervention sessions. The intervention will be considered feasible if at least 7/10 sessions are completed, on average.
10 weeks
Ease and Utility of Intervention Sessions
Time Frame: 10 weeks
Acceptability will be measured with ratings of ease and utility after each exercise, measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). The intervention will be considered acceptable if average ease and utility ratings are at least 7/10.
10 weeks

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
Change in Steps
Time Frame: Baseline and 10-Week Follow-Up
Measured by Actigraph accelerometer, in number of steps per day.
Baseline and 10-Week Follow-Up
Change in Sedentary Time
Time Frame: Baseline and 10-Week Follow-Up
Measured by Actigraph accelerometer, in minutes per day.
Baseline and 10-Week Follow-Up
Change in Optimism
Time Frame: Baseline and 10-Week Follow-Up
The Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Higher scores indicate higher levels of optimism.
Baseline and 10-Week Follow-Up
Change in Anxiety
Time Frame: Baseline and 10-Week Follow-Up
The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of anxiety.
Baseline and 10-Week Follow-Up
Change in Exercise-specific Self-efficacy
Time Frame: Baseline and 10-Week Follow-Up
Exercise-specific self-efficacy will be measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assesses self-efficacy for exercise (Range: 0-90). Higher scores indicate higher self-efficacy.
Baseline and 10-Week Follow-Up
Change in Internalized Weight Bias
Time Frame: Baseline and 10-Week Follow-Up
The Weight Bias Internalization Scale - Modified (WBIS-M) is a well-validated, 11-item measure that will be used to measure internalized weight bias (Range: 11-77). Higher scores indicate greater internalized weight bias.
Baseline and 10-Week Follow-Up
Change in Moderate to Vigorous Physical Activity (MVPA)
Time Frame: Baseline and 10-Week Follow-Up
We will use ActiGraph GT3X-BT accelerometers to objectively measure physical activity for 1 week at each assessment. MVPA will be measured in minutes/week.
Baseline and 10-Week Follow-Up
Change in Light Physical Activity
Time Frame: Baseline and 10-Week Follow-Up
Measured by Actigraph accelerometer, in minutes per week.
Baseline and 10-Week Follow-Up
Change in Depressive Symptoms
Time Frame: Baseline and 10-Week Follow-Up
The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Higher scores indicate higher levels of depression.
Baseline and 10-Week Follow-Up
Change in Motivation to Change
Time Frame: Baseline and 10-Week Follow-Up
The University of Rhode Island Change Assessment (URICA) is a well-validated, 32-item measure that will be used to assess motivation to change. Higher scores indicate higher motivation to change. Scores range from -2 to 14.
Baseline and 10-Week Follow-Up
Change in Exercise Identity
Time Frame: Baseline and 10-Week Follow-Up
The Exercise Identity Scale (EIS) is a well-validated, 9-item measure that will be used to assess the extent to which exercise contributes to one's role-identity (Range: 9-63). Higher scores indicate stronger exercise identity.
Baseline and 10-Week Follow-Up
Change in General Self-Efficacy
Time Frame: Baseline and 10-Week Follow-Up
Self-efficacy will be measured using the General Self Efficacy scale (GSE), a validated measure of self-efficacy, given its links to improved adherence. Higher scores indicate greater self-efficacy. Possible scores range from 10-40.
Baseline and 10-Week Follow-Up
Change in Body Image
Time Frame: Baseline and 10-Week Follow-Up
Body image will be assessed using the Multidimensional Body-Self Relations Questionnaire (MBSRQ) Appearance Evaluation subscale. Higher scores indicate better body image and possible scores range from 1-5.
Baseline and 10-Week Follow-Up
Change in Bariatric Surgery-specific Diet and Vitamin Adherence
Time Frame: Baseline and 10-Week Follow-Up
The Bariatric Surgery Self-Management Questionnaire (BSSQ) is a validated measure that will be used to assess adherence to diet and vitamin recommendations after bariatric surgery. Higher scores indicate better adherence to diet and vitamin recommendations. Possible scores range from 0-66.
Baseline and 10-Week Follow-Up
Change in Self-Reported Physical Activity
Time Frame: Baseline and 10-Week Follow-Up
The International Physical Activity Questionnaire (IPAQ) - Short Form is a well-validated 7-day physical activity recall assessment for physical activity. Activity will be measured by the number of minutes per day of moderate or greater activity per week.
Baseline and 10-Week Follow-Up
Change in Body Weight
Time Frame: Baseline and 10-Week Follow-Up
Body weight (in pounds) will be measured on a calibrated scale.
Baseline and 10-Week Follow-Up
Change in Waist Circumference (in Centimeters)
Time Frame: Baseline and 10-Week Follow-Up
Waist circumference will be measured by a nurse.
Baseline and 10-Week Follow-Up
Change in Systolic Blood Pressure
Time Frame: Baseline and 10-Week Follow-Up
Blood pressure will be measured by a nurse in mmHG.
Baseline and 10-Week Follow-Up
Change in Aerobic Capacity and Endurance
Time Frame: Baseline and 10-Week Follow-Up
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Baseline and 10-Week Follow-Up
Change in Social Support for Exercise
Time Frame: Baseline and 10-Week Follow-Up
The Social Support and Exercise Survey is a 13-item validated measure that assesses social support for exercising from family and friends over the past 3 months. Scores range from 20 to 200, with higher scores indicating more social support.
Baseline and 10-Week Follow-Up
Change in Social Support for Eating Habits - Encouragement Subscale
Time Frame: Baseline and 10-Week Follow-Up
The Social Support and Eating Habits Survey encouragement subscale is a 5-item validated measure that assesses social support for healthy eating from family and friends over the past 3 months. Scores range from 10 to 80, with higher scores indicating more social support.
Baseline and 10-Week Follow-Up
Change in Body Composition
Time Frame: Baseline and 10-Week Follow-Up
The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.
Baseline and 10-Week Follow-Up
Change in A1C
Time Frame: Baseline and 10-Week Follow-Up
Hemoglobin A1C will be measured via blood draw. A higher percentage means higher blood glucose values.
Baseline and 10-Week Follow-Up
Change in High-density Lipoprotein (HDL)
Time Frame: Baseline and 10-Week Follow-Up
HDL will be measured via blood draw. Higher levels of HDL in the blood means better absorption and clearing of cholesterol.
Baseline and 10-Week Follow-Up
Change in Inflammation
Time Frame: Baseline and 10-Week Follow-Up
C-reactive protein will be measured via blood draw as a measure of inflammation in mg/dL.
Baseline and 10-Week Follow-Up

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.
Massachusetts General Hospital

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 Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

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: Emily H Feig, PhD, Massachusetts General Hospital

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.
June 29, 2021

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.
June 22, 2022

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.
June 22, 2022

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).
April 28, 2021

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.
April 28, 2021

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.
April 30, 2021

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.
February 2, 2026

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.
January 14, 2026

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.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2021P001006a
  • 5K23HL148017 (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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