An interventional study of Physical Activity and Diet in Obesity, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Prevention
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.
The primary objectives of the proposed research are to:
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 55 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Case Comprehensive Cancer Center is the lead sponsor of 494 studies on the registry; 61 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 Activity · Behavioral: Diet · Behavioral: Social Support
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.
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 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.
Ratio or participants screened to patients completing 12-week measures
This is a measure of feasibility
Time frame: 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
Time frame: Up to 12 weeks
Number of eligible participants
This is a measure of feasibility
Time frame: Up to 12 weeks
Number of consented participants
This is a measure of feasibility
Time frame: Up to 12 weeks
Average change in Fitbit activity
This is a measure of physical activity
Time frame: From baseline to 12 weeks
Average change in International physical activity questionnaire (IPAQ) score
This is a measure of physical activity
Time frame: 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
This is a measure of dietary intake
Time frame: From baseline to 12 weeks
Change in weight
Trained study staff will determine weight at baseline and 12 weeks of the study
Time frame: From baseline to 12 weeks
Change in waist circumference
Trained study staff will determine waist circumference at baseline and 12 weeks of the study
Time frame: From baseline to 12 weeks
Average change in social support score
This is a 31 question, multiple choice survey adapted from Gruber and Sallis
Time frame: From baseline to 12 weeks
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
Time frame: From baseline to 12 weeks
Average change in dietary knowledge
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
Ran from Oct 2017 to primary completion in Jun 2018, 7 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 7 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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