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Completed

NCT Number: NCT03092479

Pilot Behavioral Support Intervention After Bariatric Surgery

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

About this study

Bariatric surgery patients may experience significant psychosocial changes after surgery, but little psychological support is available beyond support groups postoperatively. Psychosocial changes after surgery, including mood fluctuations, interpersonal issues and substance use, have the potential to lower quality of life and interfere with adherence to the postoperative diet and lifestyle, diminishing weight loss outcomes.

This prospective randomized pilot trial will evaluate the effect of a postoperative support program targeting quality of life, psychosocial functioning and adherence to behavior change in Geisinger Health System (GHS) bariatric surgery patients.

In this study there will be two arms. The intervention arm will include forty bariatric surgery patients (all procedure types) from the GHS Center for Nutrition and Weight Management (CNWM) who will participate in a four month bi-weekly postoperative behavioral support program to address psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain. The control arm will include 40 usual care (UC) patients from the same center that completed bariatric surgery within one year.

Both groups will complete two sets of surveys. The first set will be administered at study initiation. The second set will be administered upon completion of the 8 sessions for the intervention group. The control group will also complete surveys during this same timeframe (approximately 4-6 months after baseline survey completion).

Upon study completion, control group members will be afforded an opportunity to participate in the same postoperative behavioral support program offered to the intervention group.

The primary endpoint of this study will be quality of life with secondary endpoints including differences in psychosocial functioning (mood, eating behaviors) and adherence (diet, physical activity, appointments) as well as patient satisfaction, treatment feasibility and attrition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

    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.

Secondary outcomes

  1. Difference Between Groups in Depression Scores.

    Time frame: 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 depression scores between the Behavior Intervention and Control groups will be measured using the total score generated from the Patient Health Questionnaire (PHQ-9). Range is 0-27. Higher score means a worse outcome.

  2. Difference Between Groups in Anxiety Scores.

    Time frame: 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 anxiety weighted scores between the Behavior Intervention and Control groups will be measured using the scores generated from the State-Trait Anxiety Inventory (STAI) and is scored on a four-point Likert scale. Range is 20-80 per subtest. Higher scores indicate a worse outcome.

  3. Difference Between Groups in Measured Self-efficacy.

    Time frame: 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 self-efficacy parameters between the Behavior Intervention and Control groups will be measured by comparing responses generated from the Weight Efficacy Life-Style short-form scale (WEL-SF). Range is 0-80. Higher score indicates a better outcome

  4. Difference in Physical Activity Levels Between Groups.

    Time frame: 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.

    Differences in physical activity levels between the Behavior Intervention and Control groups will be measured by comparing hours per day spent in vigorous, moderate, light or sitting activity as recorded on the Paffenbarger Physical Activity Questionnaire (PPAQ). Calculated by minutes per week of Moderate to Vigorous Activity (MVPA).

  5. Difference in Emotional Eating Scale Results Between Groups.

    Time frame: 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.

    The Emotional Eating scale (EES) measures a subject's desire to eat in response to an emotional stimulus. This scale will be used to assess differences in emotional eating habits between the Behavior Intervention and Control groups. Subscale scores range 0-36 or 0-44. Higher scores indicates worse outcome.

  6. Differences Between Groups in Loss of Eating Control.

    Time frame: 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.

    The Loss of Control Over Eating Scale-Brief (LOCES) provides a 5 point scoring system to assess subject's loss of eating control. This scale will be used to assess differences in this measure between the Behavior Intervention and Control groups. Range is 5-35. Higher score indicates a worse outcome.

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

A Randomized Trial of a Pilot Behavioral Support Intervention After Bariatric Surgery

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 28, 2017
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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