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

Primary Purpose

Bariatric Surgery

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Positive Psychology-Motivational Interviewing

Physical Activity Education Control

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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive Psychology-Motivational Interviewing Intervention

Physical Activity Education Control

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.

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.

Outcomes

Primary Outcome Measures

Number of intervention sessions completed

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.

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/day.

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 day.

Change in Sedentary Time

Measured by Actigraph accelerometer, in minutes per day.

Change in Positive Affect

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.

Change in Negative Affect

The negative 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 negative affect (Range: 10-50). Higher scores indicate higher levels of negative affect.

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.

Change in Exercise Identity

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.

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.

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). Higher scores indicate better body image.

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.

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 MET-minutes of moderate or greater activity per week.

Change in Body weight

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

Change in Waist circumference (in centimeters)

Waist circumference will be measured by a nurse.

Change in Blood pressure (millimeters of mercury)

Blood pressure will be measured by a nurse.

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 13 to 104, with higher scores indicating more social support.

Change in Social support for eating habits

The Social Support and Eating Habits Survey is a 10-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.

Change in Lipids

Lipids will be measured via blood draw.

Change in Inflammation

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

Change in Physical activity enjoyment

Self-efficacy will be measured using the Physical Activity Enjoyment Scale (PACES), a validated measure of enjoyment during exercise. Higher scores indicate greater enjoyment during exercise.

Full Information

NCT ID

NCT04868032

First Posted

April 28, 2021

Last Updated

July 11, 2022

Sponsor

Massachusetts General Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04868032

Brief Title

Gaining Optimism After Weight Loss Surgery (GOALS) II

Acronym

GOALS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

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

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

A research assistant blinded to study condition will conduct follow-up assessment visits.

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Positive Psychology-Motivational Interviewing Intervention

Arm Type

Experimental

Arm Description

Arm Title

Physical Activity Education Control

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Positive Psychology-Motivational Interviewing

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Physical Activity Education Control

Intervention Description

Primary Outcome Measure Information:

Title

Number of intervention sessions completed

Description

Time Frame

10 weeks

Title

Ease and utility of intervention sessions

Description

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/day.

Time Frame