Weight Regain Study After Bariatric Surgery-A Pilot Project

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Withdrawn

Conditions

Weight Loss
Behavioral
Activity

Treatments

Behavioral: Behavioral lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02754453
13-129

Details and patient eligibility

About

There are three different phases to this study: Screening phase to determine if you are eligible to participate in the study. Study phase, which will entail diet and activity, exercise and then finally self monitoring goals. End of treatment phase where you will be asked to complete questionnaires.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Behavioral
Other group
Treatment:
Behavioral: Behavioral lifestyle intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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