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

NCT02867696 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-08-10

No results posted yet for this study

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

Interventions

OTHER

Standard Care

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

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Renee J. Rogers, Ph.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2021-04-29
Completion
2021-04-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02867696 on ClinicalTrials.gov