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Positive Psychology & Motivational Interviewing for Post-Bariatric Surgery (GOALS Trial)
N/A
Recruiting
Led By Emily H Feig, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult (age 18+)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 10-week follow-up, 24-week follow-up
Awards & highlights
GOALS Trial Summary
This trial looks at whether an intervention combining elements of positive psychology and motivational interviewing can help people who have had bariatric surgery become more physically active, compared to receiving enhanced usual care.
Who is the study for?
This trial is for adults over 18 who speak English and had bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two medical centers in the last 6-12 months. They should have low physical activity, want to be more active, and can talk on the phone for study sessions. People with severe mental health issues, life-threatening illnesses, or other physical activity programs are excluded.Check my eligibility
What is being tested?
The GOALS II trial is testing a program that combines positive psychology with motivational interviewing to encourage physical activity after weight loss surgery. It's compared against enhanced usual care control to see if it's feasible, acceptable, and effective.See study design
What are the potential side effects?
Since this intervention focuses on psychological support and education rather than medication or invasive procedures, side effects may include emotional discomfort due to self-reflection during therapy sessions but are generally minimal.
GOALS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
GOALS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 10-week follow-up, 24-week follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 10-week follow-up, 24-week follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ease and utility of intervention sessions
Number of intervention sessions completed
Secondary outcome measures
Change in A1C
Change in Aerobic capacity and endurance
Change in Anxiety
+25 moreGOALS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Positive Psychology-Motivational Interviewing InterventionExperimental Treatment1 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.
Group II: Physical Activity Education ControlActive Control1 Intervention
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.
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,432 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,492,441 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,799 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You cannot participate in any other physical activity program besides the ones offered at the surgery center.I cannot be physically active due to a condition like severe arthritis.You have a serious mental health condition that could prevent you from joining the study, such as psychosis or current drug addiction.I had weight loss surgery at a major hospital within the last year.You are willing to participate in activities that increase your physical activity.You have a serious illness that may cause death within the next 6 months.You don't exercise much, less than 200 minutes per week of moderate to vigorous physical activity according to your own reports.I am mentally capable of understanding and participating in the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Physical Activity Education Control
- Group 2: Positive Psychology-Motivational Interviewing Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the participation of patients in this trial?
"Affirmative. Clinicaltrials.gov outlines that this clinical trial, which was published on July 1st 2022, is accepting applications. 58 individuals must be recruited from a single site in order to fulfil the study's requirements."
Answered by AI
What is the fundamental objective of this research endeavor?
"This 10-week clinical trial will predominantly measure the user friendliness and efficacy of the intervention. Secondary results such as changes to dietary habits, delight in physical activities, and light physical activity are also pertinent outcomes that must be taken into consideration. The Bariatric Surgery Self-Management Questionnaire (BSSQ) is used to gauge adherence to diet plans while Physical Activity Enjoyment Scale (PACES) evaluates self-efficacy during exercise; both these metrics rely on higher scores for better performance. Additionally, Actigraph accelerometers track daily minutes spent performing light physical activity."
Answered by AI
Are there currently any opportunities for people to sign up as participants in this experiment?
"As indicated by clinicaltrials.gov, the trial is currently recruiting individuals and was first made public on July 1st 2022 with its most recent edit taking place 10 days later."
Answered by AI
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