NCT03337230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2017

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

November 6, 2017

Last Update Submit

March 15, 2021

Conditions

Keywords

CancerWeight-LossSocial Media

Outcome Measures

Primary Outcomes (2)

  • Ratio or participants screened to patients completing 12-week measures

    This is a measure of feasibility

    Up to 12 weeks

  • 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 Outcomes (10)

  • Number of eligible participants

    Up to 12 weeks

  • Number of consented participants

    Up to 12 weeks

  • Average change in Fitbit activity

    From baseline to 12 weeks

  • Average change in International physical activity questionnaire (IPAQ) score

    From baseline to 12 weeks

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

    From baseline to 12 weeks

  • +5 more secondary outcomes

Study Arms (1)

Physical Activity + Diet + Social media

EXPERIMENTAL

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

Behavioral: Physical ActivityBehavioral: DietBehavioral: Social Support

Interventions

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.

Physical Activity + Diet + Social media
DietBEHAVIORAL

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.

Physical Activity + Diet + Social media
Social SupportBEHAVIORAL

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.

Physical Activity + Diet + Social media

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve Univeristy

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

ObesityNeoplasmsWeight Loss

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • David N. Cavallo, PhD MPH RDN

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: pre-post study design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 8, 2017

Study Start

October 31, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations