Last reviewed · How we verify

NCT04868032: GOALS

Gaining Optimism After Weight Loss Surgery (GOALS) II

Completed NA Results posted Last updated 27 March 2026
What this trial tests

NA trial testing Positive Psychology-Motivational Interviewing in Bariatric Surgery in 58 participants. Completed in 3 June 2025.

Timeline
1 July 2022
Primary endpoint
3 February 2025
3 June 2025

Quick facts

Lead sponsorMassachusetts General Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment58
Start date1 July 2022
Primary completion3 February 2025
Estimated completion3 June 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Bariatric Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Intervention Sessions Completed Primary · 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.

GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention9.6± 1.5
Intervention Acceptability Primary · 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.

PP Topics Ease
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention8.5± 1.7
PP Topics Utility
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention8.9± 1.5
Goal Setting Topics Ease
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention8.6± 1.6
Goal Setting Topics Utility
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention9.0± 1.4
Change in Moderate to Vigorous Physical Activity (MVPA) Secondary · 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
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention109.47± 63.94
Physical Activity Education Control110.33± 105.35
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention113.05± 69.17
Physical Activity Education Control103.46± 79.96
24-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention125.75± 83.91
Physical Activity Education Control93.09± 87.83
Change in Steps Secondary · Baseline, 10-Week Follow-Up, 24-Week Follow-Up

Measured by Actigraph accelerometer, in number of steps per day.

Baseline
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention5180.53± 1722.06
Physical Activity Education Control4782.07± 1904.76
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention5219.74± 2040.10
Physical Activity Education Control4849.27± 1961.18
24-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention5306.91± 1622.68
Physical Activity Education Control4572.32± 1871.07
Change in Light Physical Activity Secondary · Baseline, 10-Week Follow-Up, 24-Week Follow-Up

Measured by Actigraph accelerometer, in minutes per day.

Baseline
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention253.28± 68.57
Physical Activity Education Control230.44± 73.03
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention253.86± 74.87
Physical Activity Education Control232.11± 77.03
24-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention245.69± 64.16
Physical Activity Education Control234.66± 62.81
Change in Positive Affect Secondary · 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
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention34.90± 7.44
Physical Activity Education Control28.28± 5.71
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention38.38± 7.36
Physical Activity Education Control30.96± 7.17
24-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention36.27± 9.30
Physical Activity Education Control32.15± 6.10
Change in Optimism Secondary · 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
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention10.28± 3.63
Physical Activity Education Control11.59± 2.77
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention10.07± 2.56
Physical Activity Education Control11.73± 2.99
24-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention10.69± 3.03
Physical Activity Education Control11.24± 2.39
Change in Depressive Symptoms Secondary · 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
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention3.34± 2.81
Physical Activity Education Control5.14± 3.46
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention2.67± 3.08
Physical Activity Education Control4.19± 3.32
24-Week Follow-Ip
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention3.42± 3.60
Physical Activity Education Control4.08± 3.19
Change in Anxiety Secondary · 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
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention6.38± 3.60
Physical Activity Education Control8± 4.01
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention5.56± 4.14
Physical Activity Education Control7.77± 4.59
24-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention5.04± 3.60
Physical Activity Education Control7.32± 4.43
Change in Exercise Identity Secondary · 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
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention30.83± 11.49
Physical Activity Education Control25.03± 11.71
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention41.04± 9.81
Physical Activity Education Control30.69± 11.60
24-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention38.19± 12.69
Physical Activity Education Control28.04± 12.26
Change in General Self-Efficacy Secondary · 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
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention32.55± 4.66
Physical Activity Education Control31.76± 3.92
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention34.00± 5.15
Physical Activity Education Control32.00± 3.37
24-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention33.65± 5.18
Physical Activity Education Control31.52± 5.06
Change in Exercise-specific Self-efficacy Secondary · 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
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention46.52± 17.21
Physical Activity Education Control45.63± 18.56
10-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention57.56± 20.27
Physical Activity Education Control37.00± 18.46
24-Week Follow-Up
GroupValue95% CI
Positive Psychology-Motivational Interviewing Intervention50.08± 21.66
Physical Activity Education Control36.96± 18.66

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were reported from enrollment until the end of follow-up, up to 32 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Positive Psychology-Motivational Interviewing Intervention
Serious: 2/29 (7%)
Deaths: 1/29
Physical Activity Education Control
Serious: 0/29 (0%)
Deaths: 0/29

Serious adverse events (2 terms)

ReactionSystemPositive Psychology-Motiva…Physical Activity Educatio…
Abdominal pain and constipationGastrointestinal disorders
CancerGeneral disorders
Other adverse events (4 terms — click to expand)

ReactionSystemPositive Psychology-Motiva…Physical Activity Educatio…
Fall, fractureInjury, poisoning and procedural complications
Muscle sprain, joint injuryInjury, poisoning and procedural complications
Reproductive system and breast disorders (Other)Reproductive system and breast disorders
PresyncopeNervous system disorders

Most-reported serious reactions: Abdominal pain and constipation, Cancer.

Data from ClinicalTrials.gov NCT04868032 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Positive Emotion-Focused Intervention to Increase Physical Activity After Bariatric Surgery: Protocol for a Pilot Randomized Controlled Trial.
    Feig EH, Harnedy LE, Thorndike AN, Psaros C, et al · · 2022 · cited 5× · PMID 36201380 · DOI 10.2196/39856

Verify or expand the search:

Other recruiting trials for Bariatric Surgery

Currently open trials in the same condition.

Other Massachusetts General Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04868032.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing