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ObesityNCT03337230

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

A study testing Physical Activity, Diet and Social Support in people with Obesity, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Physical Activity, Diet and Social Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
31 Oct 2017to 1 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • Does not meet all inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Case Western Reserve Univeristy

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: A Pilot Intervention Study to Examine the 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.

Read the 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.

Conditions
Obesity
Being tested
Physical Activity, Diet, Social Support
Keywords
Cancer, Weight-Loss, Social Media
Medical subject headings
Obesity, Neoplasms, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ActivityBehavioural

    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.

  • DietBehavioural

    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 SupportBehavioural

    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.

Study groups in NCT03337230
Study groupRoleWhat they receive
Physical Activity + Diet + Social mediaExperimentalEducational 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
Receives: Behavioral: Physical Activity; Behavioral: Diet; Behavioral: Social Support

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    This is a measure of feasibility

    Measured: Up to 12 weeks

  2. 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

    Measured: Up to 12 weeks

Secondary outcomes (10)

  1. Number of eligible participants

    This is a measure of feasibility

    Measured: Up to 12 weeks

  2. Number of consented participants

    This is a measure of feasibility

    Measured: Up to 12 weeks

  3. Average change in Fitbit activity

    This is a measure of physical activity

    Measured: From baseline to 12 weeks

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

    This is a measure of physical activity

    Measured: From baseline to 12 weeks

  5. 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

    Measured: From baseline to 12 weeks

  6. Change in weight

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

    Measured: From baseline to 12 weeks

  7. Change in waist circumference

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

    Measured: From baseline to 12 weeks

  8. Average change in social support score

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

    Measured: From baseline to 12 weeks

  9. 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

    Measured: From baseline to 12 weeks

  10. Average change in dietary knowledge

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

    Measured: From baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start31 Oct 2017
  3. Primary completion1 Jun 2018
  4. Study completion1 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
pre-post study design
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03337230
Sponsor's protocol ID
CASE17Z17
Status last verified
Mar 2021
First submitted
6 Nov 2017
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity, Diet and Social Support in people with Obesity, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio or participants screened to patients completing 12-week measures (time frame: Up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03337230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.

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