Clinical trial NCT03337230: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Cancer
Weight-Loss
Social Media
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 55
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre-post study design
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Ratio or participants screened to patients completing 12-week measures
timeFrame: Up to 12 weeks
measure: Average score of adapted INSHAPE computer-based questionnaire
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Number of eligible participants
timeFrame: Up to 12 weeks
measure: Number of consented participants
timeFrame: Up to 12 weeks
measure: Average change in Fitbit activity
timeFrame: From baseline to 12 weeks
measure: Average change in International physical activity questionnaire (IPAQ) score
timeFrame: From baseline to 12 weeks
measure: Average change in score of the National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) dietary assessment web-based assessment tool
timeFrame: From baseline to 12 weeks
measure: Change in weight
timeFrame: From baseline to 12 weeks
measure: Change in waist circumference
timeFrame: From baseline to 12 weeks
measure: Average change in social support score
timeFrame: From baseline to 12 weeks
measure: Average change in weight loss self-efficacy score
timeFrame: From baseline to 12 weeks
measure: Average change in dietary knowledge
timeFrame: From baseline to 12 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve Univeristy
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: David N. Cavallo, PhD MPH RDN
role: PRINCIPAL_INVESTIGATOR
References: