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Completed

NCT Number: NCT03337230

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

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve Univeristy

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical activity

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. Ratio or participants screened to patients completing 12-week measures

    Time frame: Up to 12 weeks

    This is a measure of feasibility

  2. 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

  1. Number of eligible participants

    Time frame: Up to 12 weeks

    This is a measure of feasibility

  2. Number of consented participants

    Time frame: Up to 12 weeks

    This is a measure of feasibility

  3. Average change in Fitbit activity

    Time frame: From baseline to 12 weeks

    This is a measure of physical activity

  4. Average change in International physical activity questionnaire (IPAQ) score

    Time frame: From baseline to 12 weeks

    This is a measure of physical activity

  5. Average change in score of the National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) dietary assessment web-based assessment tool

    Time frame: From baseline to 12 weeks

    This is a measure of dietary intake

  6. Change in weight

    Time frame: From baseline to 12 weeks

    Trained study staff will determine weight at baseline and 12 weeks of the study

  7. Change in waist circumference

    Time frame: From baseline to 12 weeks

    Trained study staff will determine waist circumference at baseline and 12 weeks of the study

  8. Average change in social support score

    Time frame: From baseline to 12 weeks

    This is a 31 question, multiple choice survey adapted from Gruber and Sallis

  9. Average change in weight loss self-efficacy score

    Time frame: From baseline to 12 weeks

    Multiple choice questions and short answer survey which can be scored to gauge weight-loss self-efficacy. Adapted from Wilson

  10. Average change in dietary knowledge

    Time frame: From baseline to 12 weeks

    Multiple choice questions and short answer survey which can be scored to gauge dietary knowledge. Adapted from Jones

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2017
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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