Gaining Optimism After Weight Loss Surgery (GOALS) I

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04867902

Acronym

GOALS

Enrollment

Registered

2021-04-30

Start date

2021-06-29

Completion date

2022-06-22

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

Keywords

Positive Psychology, Motivational Interviewing, Physical Activity

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.

Interventions

BEHAVIORALPositive Psychology-Motivational Interviewing Intervention

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Intervention Sessions Completed	10 weeks	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	10 weeks	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

Measure	Time frame	Description
Change in Moderate to Vigorous Physical Activity (MVPA)	Baseline and 10-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.
Change in Steps	Baseline and 10-Week Follow-Up	Measured by Actigraph accelerometer, in number of steps per day.
Change in Light Physical Activity	Baseline and 10-Week Follow-Up	Measured by Actigraph accelerometer, in minutes per week.
Change in Sedentary Time	Baseline and 10-Week Follow-Up	Measured by Actigraph accelerometer, in minutes per day.
Change in Optimism	Baseline and 10-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.
Change in Depressive Symptoms	Baseline and 10-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.
Change in Anxiety	Baseline and 10-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.
Change in Motivation to Change	Baseline and 10-Week Follow-Up	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	Baseline and 10-Week Follow-Up	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	Baseline and 10-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. Higher scores indicate greater self-efficacy. Possible scores range from 10-40.
Change in Exercise-specific Self-efficacy	Baseline and 10-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.
Change in Internalized Weight Bias	Baseline and 10-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: 11-77). Higher scores indicate greater internalized weight bias.
Change in Body Image	Baseline and 10-Week Follow-Up	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	Baseline and 10-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. Higher scores indicate better adherence to diet and vitamin recommendations. Possible scores range from 0-66.
Change in Self-Reported Physical Activity	Baseline and 10-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 minutes per day of moderate or greater activity per week.
Change in Body Weight	Baseline and 10-Week Follow-Up	Body weight (in pounds) will be measured on a calibrated scale.
Change in Waist Circumference (in Centimeters)	Baseline and 10-Week Follow-Up	Waist circumference will be measured by a nurse.
Change in Systolic Blood Pressure	Baseline and 10-Week Follow-Up	Blood pressure will be measured by a nurse in mmHG.
Change in Aerobic Capacity and Endurance	Baseline and 10-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.
Change in Social Support for Exercise	Baseline and 10-Week Follow-Up	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	Baseline and 10-Week Follow-Up	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	Baseline and 10-Week Follow-Up	The measurement of body fat in relation to lean body mass will be measured using bio-electrical impedance.
Change in A1C	Baseline and 10-Week Follow-Up	Hemoglobin A1C will be measured via blood draw. A higher percentage means higher blood glucose values.
Change in High-density Lipoprotein (HDL)	Baseline and 10-Week Follow-Up	HDL will be measured via blood draw. Higher levels of HDL in the blood means better absorption and clearing of cholesterol.
Change in Inflammation	Baseline and 10-Week Follow-Up	C-reactive protein will be measured via blood draw as a measure of inflammation in mg/dL.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREmily H Feig, PhD

Massachusetts General Hospital

Participant flow

Participants by arm

Arm	Count
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. 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.	12
Total	12

Arm

Count

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. 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.

Total

Baseline characteristics

Characteristic	Positive Psychology-Motivational Interviewing Intervention
Age, Continuous	45.8 years STANDARD_DEVIATION 10
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	8 Participants
Region of Enrollment United States	12 Participants
Sex: Female, Male Female	7 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 12
other Total, other adverse events	0 / 12
serious Total, serious adverse events	0 / 12

Outcome results

Primary

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.

Time frame: 10 weeks

Arm	Measure	Group	Value (MEAN)	Dispersion
Positive Psychology-Motivational Interviewing Intervention	Ease and Utility of Intervention Sessions	Positive psychology ease	8.3 units on a scale (0-10 range)	Standard Deviation 1.6
Positive Psychology-Motivational Interviewing Intervention	Ease and Utility of Intervention Sessions	Positive psychology utility	8.7 units on a scale (0-10 range)	Standard Deviation 1.4
Positive Psychology-Motivational Interviewing Intervention	Ease and Utility of Intervention Sessions	Motivational interviewing ease	8.8 units on a scale (0-10 range)	Standard Deviation 1.6
Positive Psychology-Motivational Interviewing Intervention	Ease and Utility of Intervention Sessions	Motivational interviewing utility	8.7 units on a scale (0-10 range)	Standard Deviation 1.4

Primary

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.

Time frame: 10 weeks

Arm	Measure	Value (MEAN)	Dispersion
Positive Psychology-Motivational Interviewing Intervention	Number of Intervention Sessions Completed	8.5 sessions	Standard Deviation 10

Secondary

Change in A1C

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