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

March 6, 2026 updated by: Emily Feig, Ph.D., Massachusetts General Hospital

Gaining Optimism After Weight Loss Surgery (GOALS) II: Randomized Controlled Trial of a Positive Psychology-based Intervention to Increase Physical Activity After Bariatric Surgery

This randomized controlled trial 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 compared to an enhanced usual care control.

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 compared to an enhanced usual care control. The investigators will enroll and randomize 58 participants. Study participation includes attending four study visits (two at baseline, one at 10 weeks, and one at 24 weeks). Participants will be randomized either to a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a Fitbit activity tracker, or provision of the Fitbit alone. Primary outcomes include the feasibility and acceptability of the intervention. Secondary outcomes include changes in physical activity and other psychological, behavioral, and physiological outcomes at 10 and 24 weeks compared to the control.

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.
58

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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.
  • Severe psychiatric condition limiting ability to participate (e.g., psychosis, active substance use disorder)

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.
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
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.
Active Comparator: Physical Activity Education Control
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.
Behavioral: Physical Activity Education Control
Participants randomized to this condition will be provided with a Fitbit, and will be mailed educational materials about physical activity at 4 time points throughout the intervention period. They will not receive a manual or phone calls with an interventionist.

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 for individuals randomized to the PP-MI intervention. The intervention will be considered feasible if at least 7/10 sessions are completed, on average.
10 weeks
Intervention Acceptability
Time Frame: 10 weeks
After each of the 10 weekly intervention sessions, participants will rate that week's PP and goal-setting topics on how easy they were to complete and how helpful they were. Ratings will be measured on a 10-point Likert scale (1=very difficult/not at all helpful, 10=very easy/very helpful). Ratings for each category (e.g., ease of PP exercises) will be averaged across the 10 sessions to calculate a single value for that participant. 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, 10-Week Follow-Up, 24-Week Follow-Up
Measured by Actigraph accelerometer, in number of steps per day.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Light Physical Activity
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Measured by Actigraph accelerometer, in minutes per day.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Positive Affect
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Higher scores indicate higher levels of positive affect.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Optimism
Time Frame: Baseline, 10-Week Follow-Up, 24-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, 10-Week Follow-Up, 24-Week Follow-Up
Change in Anxiety
Time Frame: Baseline, 10-Week Follow-Up, 24-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, 10-Week Follow-Up, 24-Week Follow-Up
Change in Exercise Identity
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
The Exercise Identity Scale (EIS) is a well-validated, 9-item measure that will be used to assess exercise identity (Range: 9-63). Higher scores indicate stronger exercise identity.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Exercise-specific Self-efficacy
Time Frame: Baseline, 10-Week Follow-Up, 24-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, 10-Week Follow-Up, 24-Week Follow-Up
Change in Self-Reported Physical Activity
Time Frame: Baseline, 10-Week Follow-Up, 24-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 MET-minutes of moderate or greater activity per week.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in A1C
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Hemoglobin A1C will be measured via blood draw.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Inflammation
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
C-reactive protein will be measured via blood draw as a measure of inflammation.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Moderate to Vigorous Physical Activity (MVPA)
Time Frame: Baseline, 10-Week Follow-Up, 24-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, 10-Week Follow-Up, 24-Week Follow-Up
Change in Depressive Symptoms
Time Frame: Baseline, 10-Week Follow-Up, 24-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, 10-Week Follow-Up, 24-Week Follow-Up
Change in General Self-Efficacy
Time Frame: Baseline, 10-Week Follow-Up, 24-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. The range for total scores is 10-40 with higher scores indicate greater self-efficacy. Mean total scores are reported.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Internalized Weight Bias
Time Frame: Baseline, 10-Week Follow-Up, 24-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: 1-7). Higher scores indicate greater internalized weight bias.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Bariatric Surgery-specific Diet and Vitamin Adherence
Time Frame: Baseline, 10-Week Follow-Up, 24-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. The range of scores is 0-66 with higher scores indicating better adherence to diet and vitamin recommendations. Mean total scores are reported.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Body Mass Index
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Body mass index (kilograms/meters squared) will be calculated with body weight and height measured on a calibrated scale.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Systolic Blood Pressure (Millimeters of Mercury)
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Blood pressure will be measured by a nurse.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Aerobic Capacity and Endurance
Time Frame: Baseline, 10-Week Follow-Up, 24-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, 10-Week Follow-Up, 24-Week Follow-Up
Change in Body Composition
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in HDL Cholesterol
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Physical Activity Enjoyment
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Self-efficacy will be measured using the Physical Activity Enjoyment Scale (PACES), a validated measure of enjoyment during exercise. The range of total scores is 18-126 with higher scores indicating greater enjoyment during exercise. Mean total scores are reported.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Diastolic Blood Pressure (Millimeters of Mercury)
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Blood pressure will be measured by a nurse.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in LDL Cholesterol
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Change in Triglycerides
Time Frame: Baseline, 10-Week Follow-Up, 24-Week Follow-Up
Lipids (HDL, LDL, Triglyceride) will be measured via blood draw.
Baseline, 10-Week Follow-Up, 24-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

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.
July 1, 2022

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.
February 3, 2025

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 3, 2025

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 29, 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.
March 27, 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.
March 6, 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.
March 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.
  • 2021P001006b
  • 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

product manufactured in and exported from the U.S.

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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