Pilot Behavioral Support Intervention After Bariatric Surgery

NCT03092479 | Completed Results

• 1 other identifier: 2016-0469
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized pilot trial to evaluate a comprehensive postoperative behavioral support intervention using a 4-month bi-weekly program in 40 bariatric surgery patients (all surgical procedure types) from the Geisinger Health System Center for Nutrition and Weight Management compared to 40 usual care patients.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Difference in Mean Health-Related Quality of Life (HRQoL) Scores Related to Physical Function, Energy Level and General Health.

  Health-Related Quality of Life emotional scale scores will be assessed by the SF-36-Item Short Form Health Survey between the Behavior Intervention and Control groups. This study seeks a difference of 2/3 standard deviation in scores between groups for statistical significance. Range 0-100. Higher score indicates a better outcome.

  Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.

Secondary Outcomes (6)

• Difference Between Groups in Depression Scores.

  Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.

• Difference Between Groups in Anxiety Scores.

  Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.

• Difference Between Groups in Measured Self-efficacy.

  Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.

• Difference in Physical Activity Levels Between Groups.

  Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.

• Difference in Emotional Eating Scale Results Between Groups.

  Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

4-month bi-weekly comprehensive postoperative behavioral support program addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.

Behavioral: Behavioral Intervention

Usual Care

NO INTERVENTION

Usual postoperative follow-up per the GHS Center for Nutrition and Weight Management guidelines.

Interventions

Behavioral Intervention BEHAVIORAL

Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.

Behavioral Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI\>35 kg/m2 at time of surgery
• Primary bariatric surgery completion \< 1 year
• Understanding of informed consent

You may not qualify if:

• Pregnancy
• Revision of bariatric surgery
• Significant cognitive impairment that prevents informed consent

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

Related Publications (56)

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  BACKGROUND

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  PMID: 31634365 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Under- powered to detect differences between groups and limited to presenting effect sizes only. Cohort was predominantly White, limiting generalizability of our findings. Most study outcomes were self-reported, which can be subject to bias.

Results Point of Contact

• Title: Michelle Lent, PhD
• Organization: Geisinger Clinic

mrlent1@geisinger.edu

5702141004

Study Officials

• Laura Campbell, PhD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

• Michelle Lent, PhD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 28, 2017
• Study Start: January 20, 2017
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: March 16, 2020
• Results First Posted: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)