NCT02754453

Brief Summary

There are three different phases to this study:

  1. 1.Screening phase to determine if you are eligible to participate in the study.
  2. 2.Study phase, which will entail diet and activity, exercise and then finally self monitoring goals.
  3. 3.End of treatment phase where you will be asked to complete questionnaires.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
Last Updated

April 28, 2016

Status Verified

February 1, 2016

Enrollment Period

2.3 years

First QC Date

September 25, 2013

Last Update Submit

April 25, 2016

Conditions

BehavioralActivityWeight Loss

Keywords

Weight RegainGroup TreatmentWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight Regain After Bariatric Surgery

    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.

    6 months

Secondary Outcomes (4)

  • Daily caloric intake

    6 months

  • Daily protein intake

    6 months

  • Number of minutes of physical activity

    6 months

  • Presence of disordered eating behaviors

    6 months

Study Arms (1)

Behavioral

OTHER
Behavioral: Behavioral lifestyle intervention

Interventions

Behavioral lifestyle interventionBEHAVIORAL

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.

Behavioral

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

BehaviorMotor ActivityWeight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leslie Heinberg, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2013

First Posted

April 28, 2016

Study Start

July 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

April 28, 2016

Record last verified: 2016-02

Locations

US(1)