Feasibility of a Social Media-based Weight Loss Program for Low Socioeconomic Status Individuals

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337230
• Other study ID #: CASE17Z17
• Status: Completed
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: March 2021
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Physical Activity
Fitbit Activity Monitor and IPAQ to give level of physical activity. Participants will be provided with education about physical activity recommendations and will be encouraged to set goals for improvement.
• Diet
National Cancer Institute's ASA24 web-based dietary assessment tool to determine intake. Participants will be provided with education about healthy diets and will be encouraged to set goals for making enduring changes to dietary intake.
• Social Support
Social support will be determined via self report scale measure and objective collection of social media communications. Each participant will be contacted through social media regularly with dietary and physical activity information and asked to support other participants via encouragement and sharing of information.

Locations

Country	Name	City	State
United States	Case Western Reserve Univeristy	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio or participants screened to patients completing 12-week measures	This is a measure of feasibility	Up to 12 weeks
Primary	Average score of adapted INSHAPE computer-based questionnaire	Computer-based questionnaires will be self-administered via the Qualtrics Survey platform. INSHAPE questionnaire is a 14 question survey gauging acceptability of the program	Up to 12 weeks
Secondary	Number of eligible participants	This is a measure of feasibility	Up to 12 weeks
Secondary	Number of consented participants	This is a measure of feasibility	Up to 12 weeks
Secondary	Average change in Fitbit activity	This is a measure of physical activity	From baseline to 12 weeks
Secondary	Average change in International physical activity questionnaire (IPAQ) score	This is a measure of physical activity	From baseline to 12 weeks
Secondary	Average change in score of the National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) dietary assessment web-based assessment tool	This is a measure of dietary intake	From baseline to 12 weeks
Secondary	Change in weight	Trained study staff will determine weight at baseline and 12 weeks of the study	From baseline to 12 weeks
Secondary	Change in waist circumference	Trained study staff will determine waist circumference at baseline and 12 weeks of the study	From baseline to 12 weeks
Secondary	Average change in social support score	This is a 31 question, multiple choice survey adapted from Gruber and Sallis	From baseline to 12 weeks
Secondary	Average change in weight loss self-efficacy score	Multiple choice questions and short answer survey which can be scored to gauge weight-loss self-efficacy. Adapted from Wilson	From baseline to 12 weeks
Secondary	Average change in dietary knowledge	Multiple choice questions and short answer survey which can be scored to gauge dietary knowledge. Adapted from Jones	From baseline to 12 weeks