NCT04867902

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 29, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 6, 2023

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

April 28, 2021

Results QC Date

June 22, 2023

Last Update Submit

January 14, 2026

Conditions

Keywords

Positive PsychologyMotivational InterviewingPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • Number of Intervention Sessions Completed

    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

    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 Outcomes (25)

  • Change in Moderate to Vigorous Physical Activity (MVPA)

    Baseline and 10-Week Follow-Up

  • Change in Steps

    Baseline and 10-Week Follow-Up

  • Change in Light Physical Activity

    Baseline and 10-Week Follow-Up

  • Change in Sedentary Time

    Baseline and 10-Week Follow-Up

  • Change in Optimism

    Baseline and 10-Week Follow-Up

  • +20 more secondary outcomes

Study Arms (1)

Positive Psychology-Motivational Interviewing Intervention

EXPERIMENTAL

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

Interventions

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.

Positive Psychology-Motivational Interviewing Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Emily Feig
Organization
Massachusetts General Hospital

Study Officials

  • Emily H Feig, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Psychology

Study Record Dates

First Submitted

April 28, 2021

First Posted

April 30, 2021

Study Start

June 29, 2021

Primary Completion

June 22, 2022

Study Completion

June 22, 2022

Last Updated

February 2, 2026

Results First Posted

September 6, 2023

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations