Study on Impact of Lifestyle Change and Weight Loss Before Bariatric Surgery

NCT00623792 | Completed

• 2 other identifiers: R01DK077102-01A1R01DK077102
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.

Conditions

Severe Obesity; Bariatric Surgery

Keywords

Morbid obesity; Diet therapy; Bariatric Surgery; Gastric bypass; Behavior therapy; Randomized controlled trial; Weight loss

Outcome Measures

Primary Outcomes (4)

• weight and related outcomes (BMI, cardiovascular risk, quality of life)

  pre and post intervention

• preparation for surgery (eating, activity and knowledge of surgery)

  pre and post intervention

• compliance and eating problems (vomiting, dumping, plugging etc.)

  6- and 12-months post surgery

• surgical complications and outpatient visits

  6- and 12-months post surgery

Secondary Outcomes (1)

• Weight/BMI trajectory

  pre- and post-intervention; 6-, 12 and 24 months postop

Study Arms (2)

1

NO INTERVENTION

Usual preoperative care

2

EXPERIMENTAL

Preoperative Lifestyle Intervention

Behavioral: Preoperative lifestyle Intervention

Interventions

Preoperative lifestyle Intervention BEHAVIORAL

6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 "booster" telephone calls after surgery

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any candidate for weight loss surgery who is at least 18 years old \[At the University of Pittsburgh Medical Center, bariatric surgery is recommended as a treatment for individuals with Class III obesity (BMI \> 40), or Class II obesity (BMI 35- 40) and serious obesity-related health problems\]

You may not qualify if:

• Mental retardation or psychosis
• Previously diagnosed genetic obesity syndrome
• Participation in a structured weight management program in the 6 months prior to study enrollment
• Uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment
• Pregnant or lactating in the previous 6 months
• Taking a medication known to affect body weight such as oral steroids in the previous 6 months
• Any previous surgery for weight loss
• Deemed high risk surgical candidate.

Sponsors & Collaborators

• Duquesne University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

Related Publications (1)

• Kalarchian MA, Marcus MD, Courcoulas AP, Cheng Y, Levine MD. Self-report of gastrointestinal side effects after bariatric surgery. Surg Obes Relat Dis. 2014 Nov-Dec;10(6):1202-7. doi: 10.1016/j.soard.2014.08.007. Epub 2014 Aug 23.

  PMID: 25443069 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Melissa A Kalarchian, PhD

  Duquesne University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 26, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 17, 2016

Record last verified: 2016-03

Locations

US (1)