Trial Outcomes & Findings for Weight Regain Treatment Post-Bariatric Surgery (NCT NCT04662801)
NCT ID: NCT04662801
Last Updated: 2023-11-13
Results Overview
BMI is calculated using measured height and weight- kg/m2.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
26 participants
Primary outcome timeframe
Post-treatment (3 months)
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
Behavioral Weight Loss
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
|
Behavioral Weight Loss + Medication
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Weight Regain Treatment Post-Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Behavioral Weight Loss
n=12 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
|
Behavioral Weight Loss + Medication
n=10 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.17 years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 7.71 • n=7 Participants
|
49.05 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-treatment (3 months)Population: Participants with complete data at follow up.
BMI is calculated using measured height and weight- kg/m2.
Outcome measures
| Measure |
Behavioral Weight Loss
n=9 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
|
Behavioral Weight Loss + Medication
n=7 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
|
|---|---|---|
|
Body Mass Index
|
39.12 kg/m2
Standard Deviation 4.57
|
40.48 kg/m2
Standard Deviation 4.89
|
SECONDARY outcome
Timeframe: Post-treatment (3 months)Population: Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up.
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Outcome measures
| Measure |
Behavioral Weight Loss
n=9 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
|
Behavioral Weight Loss + Medication
n=6 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
|
|---|---|---|
|
Eating Disorder Psychopathology
|
1.53 units on a scale
Standard Deviation 0.80
|
1.46 units on a scale
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Post-treatment (3 months)Population: Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up.
Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving.
Outcome measures
| Measure |
Behavioral Weight Loss
n=9 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
|
Behavioral Weight Loss + Medication
n=6 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
|
|---|---|---|
|
Food Craving
|
1.65 units on a scale
Standard Deviation 0.49
|
1.57 units on a scale
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Post-treatment (3 months)Population: Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up.
Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology
Outcome measures
| Measure |
Behavioral Weight Loss
n=9 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
|
Behavioral Weight Loss + Medication
n=6 Participants
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
|
|---|---|---|
|
Depressive Symptoms
|
3.89 units on a scale
Standard Deviation 5.21
|
3.67 units on a scale
Standard Deviation 2.58
|
Adverse Events
Behavioral Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Weight Loss + Medication
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Behavioral Weight Loss
n=12 participants at risk
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
|
Behavioral Weight Loss + Medication
n=10 participants at risk
Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
30.0%
3/10 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
40.0%
4/10 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
50.0%
5/10 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
|
General disorders
Dizziness
|
0.00%
0/12 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
30.0%
3/10 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
|
General disorders
Dry mouth
|
0.00%
0/12 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
50.0%
5/10 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
|
General disorders
Headache
|
0.00%
0/12 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
30.0%
3/10 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
|
General disorders
Insomnia
|
0.00%
0/12 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
20.0%
2/10 • Up to 3 months
Adverse events were collected for both arms however, the on label listed potential side effects for the drug were used to assess participants in the '+ drug' arm systematically.
|
Additional Information
Dr Valentina Ivezaj, Assistant Professor of Psychiatry
Yale School of Medicine
Phone: +1 (203) 785-7807
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place