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Clinical Trials/NCT03337230
NCT03337230
Completed
Not Applicable

A Pilot Intervention Study to Examine the Feasibility of a Social Media-Based Weight Loss Program for Low Socioeconomic Status Individuals

Case Comprehensive Cancer Center1 site in 1 country55 target enrollmentOctober 31, 2017
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Case Comprehensive Cancer Center
Enrollment
55
Locations
1
Primary Endpoint
Ratio or participants screened to patients completing 12-week measures
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to see if it is practical to use social media-based and traditional online weight loss intervention components among low socioeconomic status participants using the Facebook social media (SM) and Fitbit self-monitoring platforms. Also, the study will test the effectiveness of recruiting participants via social media and at community events and locations. The results of this study will be used to inform future research studies.

Detailed Description

The primary objectives of the proposed research are to: 1. assess the feasibility of social media-based (social support, social competition, and social rewards) and traditional online weight loss (education and goal setting) intervention components delivered to low-Socioeconomic Status (SES) participants using the Facebook SM and Fitbit self-monitoring platforms and 2. develop and assess methods for recruiting and retaining adequate numbers of low-SES participants for a future randomized controlled trial to assess the efficacy of an SM-based weight loss intervention. The study team will assess feasibility by conducting a 12-week pilot test of traditional and social media-based weight loss intervention components followed by qualitative and quantitative assessment with pilot participants. The specific aims are: Aim 1- Assess trial feasibility: The study team will assess intervention processes critical to the success of a larger efficacy trial during the 12-week pilot including: (1) participant recruitment and retention, (2) participant use of intervention components, (3) use of data collection strategies and instruments. Aim 2 - Assess intervention acceptability: The study team will conduct structured interviews and surveys among participants to assess participants' experience during the intervention. This study focuses on: (1) intervention design and content, (2) participant use of intervention technologies (Facebook and Fitbit), (3) participant concerns about privacy, and (4) barriers and facilitators to recruitment, retention, and participation. Findings will be used to improve the design of a larger efficacy trial. Study Design: This study will employ a one group pre-post design.

Registry
clinicaltrials.gov
Start Date
October 31, 2017
End Date
June 1, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • able to speak English
  • regular access to an internet-enabled device that can be synched with the Fitbit wristband
  • Body mass index (BMI) 25-40 kg/m\^2
  • \< 30 minutes per day of self-reported moderate or vigorous physical activity
  • Considered eligible for Ohio Expanded Food and Nutrition Education Program (EFNEP) income guidelines
  • located in the greater Cleveland metropolitan area
  • not pregnant or planning on becoming pregnant
  • answers 'no' to all questions on the PA Readiness Questionnaire (PAR-Q) or is cleared in writing by a physician
  • does not have a recent history of alcohol or drug abuse or is in treatment
  • does not have schizophrenia

Exclusion Criteria

  • Does not meet all inclusion criteria

Outcomes

Primary Outcomes

Ratio or participants screened to patients completing 12-week measures

Time Frame: Up to 12 weeks

This is a measure of feasibility

Average score of adapted INSHAPE computer-based questionnaire

Time Frame: Up to 12 weeks

Computer-based questionnaires will be self-administered via the Qualtrics Survey platform. INSHAPE questionnaire is a 14 question survey gauging acceptability of the program

Secondary Outcomes

  • Average change in score of the National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) dietary assessment web-based assessment tool(From baseline to 12 weeks)
  • Number of eligible participants(Up to 12 weeks)
  • Number of consented participants(Up to 12 weeks)
  • Change in weight(From baseline to 12 weeks)
  • Average change in International physical activity questionnaire (IPAQ) score(From baseline to 12 weeks)
  • Change in waist circumference(From baseline to 12 weeks)
  • Average change in Fitbit activity(From baseline to 12 weeks)
  • Average change in social support score(From baseline to 12 weeks)
  • Average change in weight loss self-efficacy score(From baseline to 12 weeks)
  • Average change in dietary knowledge(From baseline to 12 weeks)

Study Sites (1)

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