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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity
Diet
Social Support
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Cancer, Weight-Loss, Social Media

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Case Western Reserve Univeristy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical Activity + Diet + Social media

Arm Description

Educational materials for the proposed study will be delivered via a secret social media Facebook group. These materials will promote simple, attainable forms of Physical Activity and lasting diet changes. A study moderator will deliver weekly communications to the Facebook group providing intervention content including social support, social competition and comparison, and social rewards

Outcomes

Primary Outcome Measures

Ratio or participants screened to patients completing 12-week measures
This is a measure of feasibility
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

Secondary Outcome Measures

Number of eligible participants
This is a measure of feasibility
Number of consented participants
This is a measure of feasibility
Average change in Fitbit activity
This is a measure of physical activity
Average change in International physical activity questionnaire (IPAQ) score
This is a measure of physical activity
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
Change in weight
Trained study staff will determine weight at baseline and 12 weeks of the study
Change in waist circumference
Trained study staff will determine waist circumference at baseline and 12 weeks of the study
Average change in social support score
This is a 31 question, multiple choice survey adapted from Gruber and Sallis
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
Average change in dietary knowledge
Multiple choice questions and short answer survey which can be scored to gauge dietary knowledge. Adapted from Jones

Full Information

First Posted
November 6, 2017
Last Updated
March 15, 2021
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03337230
Brief Title
Feasibility of a Social Media-based Weight Loss Program for Low Socioeconomic Status Individuals
Official Title
A Pilot Intervention Study to Examine the Feasibility of a Social Media-Based Weight Loss Program for Low Socioeconomic Status Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Cancer, Weight-Loss, Social Media

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pre-post study design
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical Activity + Diet + Social media
Arm Type
Experimental
Arm Description
Educational materials for the proposed study will be delivered via a secret social media Facebook group. These materials will promote simple, attainable forms of Physical Activity and lasting diet changes. A study moderator will deliver weekly communications to the Facebook group providing intervention content including social support, social competition and comparison, and social rewards
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ratio or participants screened to patients completing 12-week measures
Description
This is a measure of feasibility
Time Frame
Up to 12 weeks
Title
Average score of adapted INSHAPE computer-based questionnaire
Description
Computer-based questionnaires will be self-administered via the Qualtrics Survey platform. INSHAPE questionnaire is a 14 question survey gauging acceptability of the program
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Number of eligible participants
Description
This is a measure of feasibility
Time Frame
Up to 12 weeks
Title
Number of consented participants
Description
This is a measure of feasibility
Time Frame
Up to 12 weeks
Title
Average change in Fitbit activity
Description
This is a measure of physical activity
Time Frame
From baseline to 12 weeks
Title
Average change in International physical activity questionnaire (IPAQ) score
Description
This is a measure of physical activity
Time Frame
From baseline to 12 weeks
Title
Average change in score of the National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) dietary assessment web-based assessment tool
Description
This is a measure of dietary intake
Time Frame
From baseline to 12 weeks
Title
Change in weight
Description
Trained study staff will determine weight at baseline and 12 weeks of the study
Time Frame
From baseline to 12 weeks
Title
Change in waist circumference
Description
Trained study staff will determine waist circumference at baseline and 12 weeks of the study
Time Frame
From baseline to 12 weeks
Title
Average change in social support score
Description
This is a 31 question, multiple choice survey adapted from Gruber and Sallis
Time Frame
From baseline to 12 weeks
Title
Average change in weight loss self-efficacy score
Description
Multiple choice questions and short answer survey which can be scored to gauge weight-loss self-efficacy. Adapted from Wilson
Time Frame
From baseline to 12 weeks
Title
Average change in dietary knowledge
Description
Multiple choice questions and short answer survey which can be scored to gauge dietary knowledge. Adapted from Jones
Time Frame
From baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David N. Cavallo, PhD MPH RDN
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve Univeristy
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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

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