Weight Regain Study After Bariatric Surgery-A Pilot Project

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02754453
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

There are three different phases to this study:

1. Screening phase to determine if you are eligible to participate in the study.

2. Study phase, which will entail diet and activity, exercise and then finally self monitoring goals.

3. End of treatment phase where you will be asked to complete questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Behavioral; Activity; Weight Loss	Behavioral: Behavioral lifestyle intervention	N/A

Detailed Description

The purpose of this study is to determine the feasibility of a group treatment program for individuals experiencing weight regain after bariatric surgery and to evaluate the effectiveness of the group treatment program. There is little information on programs to assist patients who experience weight regain after bariatric surgery. This treatment program will focus on behavioral changes and activity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Evaluation of the Efficacy of a Group Treatment Intervention for Weight Regain After Bariatric Surgery-A Pilot Project
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Behavioral	Behavioral: Behavioral lifestyle intervention; 20 session lifestyle behavioral intervention with the goal of altering diet and physical activity and decreasing problematic behaviors associated with weight regain and session behavioral intervention addressing increasing physical activity, improving adherence to dietary recommendations and altering problematic eating behaviors.

Outcome Measures

Primary Outcome Measures

1. Weight Regain After Bariatric Surgery [6 months]

   The overall goal of the project is to collect pilot data for a RO1 application. The primary outcome will be kg lost and BMI units lost from pre- to post-treatment. The effect size (Mean1 - Mean2 / pooled s.d.) of the intervention will be determined for within subject and between subject differences. It is hypothesized that a moderate effect size (.5) will be demonstrated and that has been selected a priori as the criteria for pursuing a larger-scale randomized clinical trial.

Secondary Outcome Measures

1. Daily caloric intake [6 months]

   Subjects will keep a food intake diary and bring it to their appointments where calorie intake will be calculated

2. Daily protein intake [6 months]

   Subjects will keep a food intake diary and bring it to their appointment where daily protein intake will be calculated

3. Number of minutes of physical activity [6 months]

   Subjects will wear a pedometer to track their daily activity

4. Presence of disordered eating behaviors [6 months]

   Subjects will complete pre and post treatment questionnaires to assess for disordered eating behaviors

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Weight regain post-RYGB of at least 5 kg since reaching their weight nadir.

• Male or Female age 18 - 65.

• Undergone RYGB 12 - 36 month prior.

• Ability to read, write and understand English.

• Experienced at least a 25% total weight loss since surgery.

• BMI at least 27 kg/m.

• Weight regain of no more than half of excess body weight. These cases will be referred back to the surgeon.

Exclusion Criteria:

• Taking Weight-suppressing medication (e.g. phentermine, bupropion)

• On medications known to cause weight gain

• Change in smoking status with past three months

• Change in antidepressant or other psychotropic medication or dosage in past six weeks

• Change in psychotherapy status in past six weeks

• Current purging behaviors occurring more than once per week over the past six weeks (vomiting or laxative/diuretic use for the purpose of weight loss

• Current alcohol abuse or dependence or illicit drug use in past three months

• Active bipolar or psychotic spectrum disorder

• Current suicidality or homicidality

• Severe neuropsychological disease (history of seizure, uncontrolled hypertension

• Condition associated with cognitive dysfunction (e.g. Alzheimer's dementia, other neurological conditions)

• Medically unstable condition or one which the investigators feel put the participant at risk in the study

• Functional limitations-not able to walk 2 block without assistance

• Exercise is contra-indicated (e.g., severe cardiovascular disease, uncontrolled hypertension, hematocrit.<30%, chronic kidney disease, severe pulmonary disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Leslie Heinberg, PhD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02754453
• Other Study ID Numbers: 13-129
• First Posted: Apr 28, 2016
• Last Update Posted: Apr 28, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by The Cleveland Clinic: Weight Regain; Group Treatment; Weight Loss
• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

No Results Posted as of Apr 28, 2016