Gaining Optimism After Weight Loss Surgery (GOALS) I - Clinical Trial for Bariatric Surgery | NCT04867902

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Positive Psychology-Motivational Interviewing Intervention

About this trial

This is an interventional treatment trial for Bariatric Surgery focused on measuring Positive Psychology, Motivational Interviewing, Physical Activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positive Psychology-Motivational Interviewing Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Change in Moderate to Vigorous Physical Activity (MVPA)

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.

Change in Steps

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

Change in Light Physical Activity

Measured by Actigraph accelerometer, in minutes per week.

Change in Sedentary Time

Measured by Actigraph accelerometer, in minutes per day.

Change in Optimism

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.

Change in Depressive Symptoms

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.

Change in Anxiety

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.

Change in Motivation to Change

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.

Change in Exercise Identity

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.

Change in General Self-Efficacy

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.

Change in Exercise-specific Self-efficacy

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.

Change in Internalized Weight Bias

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.

Change in Body Image

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.

Change in Bariatric Surgery-specific Diet and Vitamin Adherence

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.

Change in Self-Reported Physical Activity

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.

Change in Body Weight

Body weight (in pounds) will be measured on a calibrated scale.

Change in Waist Circumference (in Centimeters)

Waist circumference will be measured by a nurse.

Change in Systolic Blood Pressure

Blood pressure will be measured by a nurse in mmHG.

Change in Aerobic Capacity and Endurance

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.

Change in Social Support for Exercise

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.

Change in Social Support for Eating Habits - Encouragement Subscale

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.

Change in Body Composition

The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.

Change in A1C

Hemoglobin A1C will be measured via blood draw. A higher percentage means higher blood glucose values.

Change in High-density Lipoprotein (HDL)

HDL will be measured via blood draw. Higher levels of HDL in the blood means better absorption and clearing of cholesterol.

Change in Inflammation

C-reactive protein will be measured via blood draw as a measure of inflammation in mg/dL.

Full Information

NCT ID

NCT04867902

First Posted

April 28, 2021

Last Updated

August 11, 2023

Sponsor

Massachusetts General Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04867902

Brief Title

Gaining Optimism After Weight Loss Surgery (GOALS) I

Acronym

GOALS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

June 29, 2021 (Actual)

Primary Completion Date

June 22, 2022 (Actual)

Study Completion Date

June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bariatric Surgery

Keywords

Positive Psychology, Motivational Interviewing, Physical Activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Positive Psychology-Motivational Interviewing Intervention

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Positive Psychology-Motivational Interviewing Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Intervention Sessions Completed

Description

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.

Time Frame

10 weeks

Title

Ease and Utility of Intervention Sessions

Description

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.

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Change in Moderate to Vigorous Physical Activity (MVPA)

Description

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.

Time Frame