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

NCT02867696 | Terminated

• 1 other identifier: PRO14060446
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Motor Activity; Weight Loss

Keywords

Bariatric Surgery; Physical Activity; Weight Management; Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 year after bariatric surgery - months 12-18 (6 month intervention period)

Secondary Outcomes (17)

• To examine the effect of TECH and Standard Care on change in body composition.

  1 year after bariatric surgery - months 12-18 (6 month intervention period)

• To examine the effect of TECH and Standard Care on change in cardiorespiratory fitness.

  1 year after bariatric surgery - months 12-18 (6 month intervention period)

• To examine the effect of TECH and Standard Care on change in physical activity (Paffenbarger)

  1 year after bariatric surgery - months 12-18 (6 month intervention period)

• To examine the effect of TECH and Standard Care on change in physical activity (GPAQ)

  1 year after bariatric surgery - months 12-18 (6 month intervention period)

• To examine the effect of TECH and Standard Care on change in physical activity (objective monitor)

  1 year after bariatric surgery - months 12-18 (6 month intervention period)

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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

Technology-based Intervention (TECH)

EXPERIMENTAL

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)

Interventions

Standard Care OTHER

Subjects in this arm will receive the standard care that is provided by their bariatric surgical team following bariatric surgery.

Standard Care

Technology-based Intervention (TECH) BEHAVIORAL

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.

Technology-based Intervention (TECH)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Physical Activity and Weight Management Research Center / University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Motor Activity; Weight Loss

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Renee J. Rogers, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: August 16, 2016
• Study Start: January 1, 2015
• Primary Completion: April 29, 2021
• Study Completion: April 29, 2021
• Last Updated: August 10, 2021

Record last verified: 2020-03

Locations

US (1)