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Effect of a Technology-Based Intervention on Weight Change Post-Bariatric Surgery

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Renee J. Rogers, University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Renee J. Rogers, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02867696
First received: May 5, 2016
Last updated: August 22, 2017
Last verified: August 2017
  Purpose
The primary aim of this study is to examine the effect of applying a minimal contact technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change compared to Standard Care. Forty participants at 1-year post bariatric surgery will be randomized to TECH or Standard Care for a period of 6 months (12 to 18 months post-surgery). Analyses will be conducted to compare these interventions for differences in body weight, body composition, fitness, physical activity, engagement, psychosocial measures, and intervention cost and cost-effectiveness of each approach. TECH will consist of a wearable monitor that provides feedback on energy expenditure and physical activity, electronic tracking of dietary intake, and integration of an electronic scale to provide comprehensive feedback to the participant on all components of weight management. TECH participants will receive a monthly telephone call from the intervention staff to provide guidance on their weight management efforts.

Condition Intervention
Motor Activity Weight Loss Other: Standard Care Behavioral: Technology-based Intervention (TECH)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of a Technology-Based Intervention on Weight Change Post-Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Renee J. Rogers, University of Pittsburgh:

Primary Outcome Measures:
  • To examine the effect of applying a minimal contact technology-based intervention (TECH) at 1-year post-bariatric surgery on weight change compared to Standard Care over the subsequent 6 months. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    Body Weight (5 minutes; 0, 3, 6 months): Body weight will be measured to the nearest 0.1 kg on a Tanita WB-110A digital scale (Tanita Corporation; Arlington Heights, IL). Measures will be taken in a light-weight hospital gown with shoes and accessories removed.


Secondary Outcome Measures:
  • To examine the effect of TECH and Standard Care on change in body composition. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]

    Regional Adiposity by Anthropometry (5 minutes; 0, 6 months): Taken in a lightweight hospital gown and measured to the nearest 0.1 cm using a Gulick tape measure. Waist circumference will be taken from the front at the level of the iliac crest. Hip circumferences will be taken from the side while making a horizontal circumference at the maximal protrusion of the gluteal muscles.

    Body Composition (30 minutes total; 0, 6 months): Body composition will be assesses using 2 methods (1) bioelectrical impedance analysis (BIA), and (2) dual xray absorptiometry (DXA).


  • To examine the effect of TECH and Standard Care on change in cardiorespiratory fitness. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    Cardiorespiratory Fitness: (40 minutes; 0, 6 months): Subjects will complete a graded exercise test on a treadmill using indirect calorimetry to measure peak oxygen consumption. With peak oxygen used to define cardiorespiratory fitness.

  • To examine the effect of TECH and Standard Care on change in physical activity (Paffenbarger) [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]

    Physical activity (0, 3, 6 months) will be assessed using self-report questionnaire: Paffenbarger Physical Activity Questionnaire (Paffenbarger 1986)

    This questionnaire will provide minute/week data on moderate-to-vigorous physical activity performed with walking, stair climbing, and other recreational/fitness activities.


  • To examine the effect of TECH and Standard Care on change in physical activity (GPAQ) [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]

    Physical activity (0, 3, 6 months) will be assessed using self-report questionnaire: Global Physical Activity Questionnaire (GPAQ)

    This questionnaire will provide minute/week data on occupational, household, leisure and recreational, and transportation physical activities.


  • To examine the effect of TECH and Standard Care on change in physical activity (objective monitor) [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]

    Physical activity (0, 3, 6 months) will be assessed using an objective physical activity monitor: Sensewear Pro Armband

    This monitor (worn for 7 consecutive days) will provide minute/week data on sedentary, light, and moderate-to-vigorous physical activity.


  • To examine the effect of TECH and Standard Care on change in sedentary behavior. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]

    Sedentary Behavior (0, 3, 6 months) will be assessed using self-report questionnaire: Sedentary Behavior Questionnaire

    This questionnaire will provide data on total time spent in sedentary activities on week and weekend days.


  • To examine the effect of TECH and Standard Care on change in dietary intake. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    The Block Food Frequency Questionnaire will be used to assess the usual frequency of specific foods and typical portion sizes.

  • To examine the effect of TECH and Standard Care on change in eating behavior. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    The Eating Behavior Inventory will be used to assess eating behaviors and behaviors that may be related to successful weight loss such as self-monitoring of intake, refusing food, shopping practices, and emotional eating.

  • To examine the effect of TECH and Standard Care on change in exercise barriers. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    The Exercise Outcome, Expectations and Barriers questionnaire will be used to assess physical activity and exercise engagement and barriers.

  • To examine the effect of TECH and Standard Care on change in physical activity self-efficacy. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    The Physical Activity Self-Efficacy questionnaire will be used to assess the subjects' confidence and self-efficacy for being physically active.

  • To examine the effect of TECH and Standard Care on change in health perception. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    The SF-36 questionnaire will be used to assess perceptions of their health.

  • To examine the effect of TECH and Standard Care on change in weight loss and diet expectations and barriers [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    The Weight Loss Expectations and Barriers questionnaire will be used to assess perceptions around benefits and difficulties of weight loss and weight management.

  • To examine the effect of TECH and Standard Care on change in cognitive restraint and disinhibition with eating behaviors [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    The 3-Factor Eating/Eating Inventory questionnaire will be used to assess cognitive restraint, disinhibition, and perceived hunger related to eating behaviors.

  • To examine the effect of TECH and Standard Care on change in body image [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    The Multidimensional Body-Self Relations/Body Image Scale questionnaire will be used to assess body image.

  • To examine the effect of TECH and Standard Care on change in depression symptoms [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]
    The CES-D (short form) will be uses to assess depressive symptoms.

  • To examine satisfaction related to technology usage for weight management [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) - collected at 6 months ]
    A survey will be administered to determine subject satisfaction related to technology usage during the study and interest in potential continued usage. This will be administered at 6 months to the TECH group only.

  • To conduct analyses to examine the cost and cost effectiveness of TECH and Standard Care interventions. [ Time Frame: 1 year after bariatric surgery - months 12-18 (6 month intervention period) ]

    Analyses of cost will be broken down by payer, participant, and societal perspectives.

    Payer costs referring to labor (time, wage) plus non-labor (materials, fixed costs, intervention-specific materials) costs.

    Participant costs including Time in minutes (in-person, phone calls), Attendance (transit minutes, inperson attendance), Wage based on BLS average, and Transport (transportation costs).

    Total Social costs will be the sum of Payer and Participant costs.



Estimated Enrollment: 30
Study Start Date: January 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Care
Standard Care serves as the no treatment control in this project. Participants in this group will receive the typical care from their surgeon following bariatric surgery. No additional interventions will be given to participants randomized to this group.
Other: Standard Care
Subjects in this arm will receive the standard care that is provided by their bariatric surgical team following bariatric surgery.
Experimental: Technology-based Intervention (TECH)
TECH is the experimental group in this project. A minimal-contact technology-based intervention for weight management will be given to this group in addition to the standard or typical care received from their surgeon following bariatric surgery.
Behavioral: Technology-based Intervention (TECH)

Dietary recommendations: based on the subjects' baseline body weight, with calorie goals ranging from 1200-2100 kcal/day.

The physical activity component: unsupervised home-based exercise program. Intensity/Mode: aerobic physical activity recommended at a moderate intensity. Prescription: progress to 250 min/wk by 13th week of the intervention.

Self-monitoring: Jawbone UP3 System includes a wearable device to monitor physical activity and energy expenditure that will transmit real-time feedback on calories expended and physical activity directly to a smart phone. An integrated digital smart scale will also be provided.

Contact: scheduled intervention telephone call: Month 1: One call per week for the first 4 weeks of the study; Months 2-6: One call per month.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 18-60 years.
  • 1-year post-bariatric surgery.
  • Able to walk at 3 miles per hour during a cardiorespiratory fitness test.

Exclusion Criteria:

  • Reports not having access to a computer, access to the Internet, email, or the availability to download software onto a computer.
  • Reports not having a smart phone device that is compatible with the Jawbone UP3 System that will be examined in this study.
  • Has a physical limitation that would prevent engaging in physical activity.
  • Reports being treated for a current medical condition that could affect body weigh (diabetes mellitus, cancer, chronic renal insufficiency, hyperthyroidism, hypothyroidism, chronic liver disease).
  • Reports current congestive failure, angina, uncontrolled arrhythmia, symptoms indicative of increased risk of an acute cardiovascular event, coronary artery bypass grafting or angioplasty, prior myocardial infarction, and conditions requiring anticoagulation therapy (deep vein thrombosis).
  • Has a resting systolic blood pressure ≥ 150 mmHg or resting diastolic blood pressure of ≥100 mmHg or taking medication to control blood pressure that affects heart rate.
  • Reports being treated for a psychological issue (i.e., depression, bipolar disorder, etc).
  • Taking prescription or over-the-counter medications that affect body weight and metabolism.
  • Currently participating in an exercise or weight control study or a current participant in a commercial weight reduction program.
  • Currently being treated for an eating disorder.
  • Currently pregnant, pregnant in the last 6 months, breast feeding in the last 3 months, lactating, to planning on becoming pregnant in the next 6 months.
  • Planning on relocating outside of the greater Pittsburgh area within the next 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02867696

Contacts
Contact: Renee J. Rogers, Ph.D. 412-383-4015 r.j.rogers@pitt.edu
Contact: John M. Jakicic, Ph.D. 412-383-4001 jjakicic@pitt.edu

Locations
United States, Pennsylvania
Physical Activity and Weight Management Research Center / University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Renee J. Rogers, PhD    412-383-4015    r.j.rogers@pitt.edu   
Principal Investigator: Renee J. Rogers, PhD         
Sub-Investigator: John M. Jakicic, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Renee J. Rogers, Ph.D. University of Pittsburgh
  More Information

Responsible Party: Renee J. Rogers, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02867696     History of Changes
Other Study ID Numbers: PRO14060446
Study First Received: May 5, 2016
Last Updated: August 22, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not known at this time if data will be shared at the conclusion of the project.

Keywords provided by Renee J. Rogers, University of Pittsburgh:
Bariatric Surgery
Physical Activity
Weight Management
Weight Loss

Additional relevant MeSH terms:
Body Weight
Weight Loss
Body Weight Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 25, 2017