Clinical trial NCT04412954: Improving Cardiovascular Risk Factors in Black Young Adults
Official title: Improving Cardiovascular Risk Factors in Black Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: minority
College Student
Nutrition
Physical Activity
Health Coach
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 256
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of the study are to conduct a randomized controlled trial to test the efficacy of the Smartphone intervention on % weight loss and maintaining % weight loss at 6 and 12 months in a sample (N=256) of Black community college students who are overweight or obese, ages 18-25 years. Investigators will also examine mediating variables of the intervention on weight at 6 and 12 months, including adherence to self-monitoring, discrimination, and dietary and physical activity self-efficacy. In addition, investigators will explore potential moderators of weight loss at 6 months and 12 months, including depressive symptoms, ideal body image, and motivation.

Detailed description: A total of 256 students, ages 18-25, who meet the inclusion and exclusion criteria will be recruited from Columbus State Community College (CSCC). A sample size of 256 subjects (n=128 per each trial arm) will have sufficient power (\>80%) to detect an average between-group difference with a moderate effect size of 0.4. The mixed effect modeling for repeated outcome measures at 6 and 12 months was used for the power calculation using two-sided significance level of 0.05 assuming 1) first-order autoregressive covariance structure, 2) the within-structure correlation of 0.8, and 3) 20% attrition rate at 12-month follow-up. The effect size of 0.4 was reasonably assumed based on data from published trials on weight-loss interventions (an effect size of 0.8 using 8-week social media, 0.3 using 12-week Smartphone intervention, and 0.6 using 4-month text messaging). Investigators will conduct stratified recruitment by gender (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black) to achieve a study sample with 80% Non-Hispanic Black and 20% Hispanic and 50% male in each ethnic group. The recruitment and randomization will be equally distributed with approximately 10 subjects per month, which is a feasible enrollment target considering the pool of eligible participants and our previous recruitment success.

Prospective participants who contact through telephone or email will undergo a preliminary screening via telephone and receive an explanation of the study. Included in this screening are four questions from the Eating Attitude Test-26 (EAT-26), which will be asked to determine symptoms of disordered eating in the past 6 months. Those who seem to meet eligibility criteria and are interested in participating will be scheduled for an in person visit for the informed consent and screening process.

Following the informed consent process and baseline visit questionnaires, participants will be randomly assigned to intervention or the attention-control group. Investigators will use stratified randomization by sex (female vs. male) and ethnicity (Non-Hispanic Black vs. Hispanic Black). For each gender strata, randomization will occur in permuted blocks of varying block sizes. Subjects in each block will be randomly assigned to intervention arm or attention-control arm with an allocation ratio of 1:1. The advantage of permuted block randomization is that it will ensure balance in the number of subjects in the two trial arms during the entire study period.

Eligibility criteria: Inclusion

* age 17-25 years
* Current CSCC student
* Identify as Black
* BMI ≥ 25
* Speaks and reads English
* Interested in losing weight through diet and physical activity changes
* Owns a smartphone or iPhone Operating System (iOS) or Android compatible device
* Ability to return for 12-month visit

Exclusion

* currently pregnant or planning to become pregnant in next 12 months
* Currently participating in another structured weight loss program or taking weight loss medications or medication known to increase weight
* Lost 10% or more of body weight in past 6 months
* Screens positive for disordered eating symptoms
* diagnosed with type I diabetes

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline to 12 months
measure: Physical Activity-Active Minutes/Day
timeFrame: 12 months
measure: Physical Activity-Steps/Day
timeFrame: 12 months
measure: Food Frequency Questionnaire (FFQ)
timeFrame: 12 months
measure: Healthy Eating Index (HEI)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Participants Who Are Adherent to Self-Monitoring
timeFrame: Baseline to 12 months
measure: Dietary Self-Efficacy Scale (Diet-SE)
timeFrame: 12 months
measure: Self-Efficacy for Exercise Scale
timeFrame: 12 months
measure: Experiences of Discrimination Scale (EoD)
timeFrame: 12 months
measure: Patient Health Questionnaire (PHQ) for Adults, PHQ-9
timeFrame: 12 months
measure: Ideal Body Image
timeFrame: 12 months
measure: Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise
timeFrame: 12 months
measure: NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References:
citation: Stephens J, Randolph J, Burke L, Miller C, Tan A, Buffington B, Melnyk B, Perkins A. A randomized controlled trial for reduction of risk factors for cardiovascular disease in young adults: Methods of the Aspire study. Contemp Clin Trials. 2022 Oct;121:106873. doi: 10.1016/j.cct.2022.106873. Epub 2022 Sep 5.
citation: Leissa SM, Randolph JC, Stephens JD. Recruitment of Black Identifying Young Adults into Clinical Trials: a Report from the Field. J Urban Health. 2021 Oct;98(Suppl 2):155-159. doi: 10.1007/s11524-021-00569-4. Epub 2021 Aug 13. No abstract available.