Improving Cardiovascular Risk Factors in Black Young Adults

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Smartphone + Text Messaging with Health Coach

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.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Health coach with Smartphone application for diet and physical activity	Behavioral: Smartphone + Text Messaging with Health Coach; The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit.
No Intervention: Control; No intervention, using a Smartphone application for sleep monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)	Baseline to 12 months
Physical Activity-Active Minutes/Day	Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average active minutes per day will be used as measurement. This data represents active minutes per day at 12 months	12 months
Physical Activity-Steps/Day	Will be measured objectively using the FitBit Charge for 7 days at each time period of data collection. Average steps taken per day will be used as measurement.	12 months
Food Frequency Questionnaire (FFQ)	The full-length block FFQ will be used to assess diet for 7 days at each period of data collection. This is not a scale, this is a measure of foods consumed over a period of 7 days. We measured and target sodium as the nutrient of choice to analyze	12 months
Healthy Eating Index (HEI)	A healthy eating index score will be calculated at each time period from the FFQ. The scale ranges from 0-100 with 100 being the best possible score indicating healthy diet aligning with key dietary recommendations.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Participants Who Are Adherent to Self-Monitoring	Intervention condition only. Adherence will be defined as those participants who enter at least 50% of their caloric goal on at least 80% of days (or 24 days per months).	Baseline to 12 months
Dietary Self-Efficacy Scale (Diet-SE)	14 questions that examine the participant's belief in their ability to cut down on high caloric foods. Scale ranges from 0-4 with 0 being "not at all confident" and 4 being "very confident" Higher overall score indicates higher levels of self confidence. Total score ranges from 0-56. Total score is reported.	12 months
Self-Efficacy for Exercise Scale	9 questions that examine the participant's belief in their ability to complete physical activity in given circumstances. Scale ranges from 0-10 with 0 being not at all confident and 10 being the most confident. Overall scores range from 0-90 with 90 indicating high confidence levels for exercise.	12 months
Experiences of Discrimination Scale (EoD)	Examines perceived experiences of discrimination in given circumstances, such as work, public settings, banks, schools, medical care. 17 questions total. Scale ranges from never to four or more times. Four or more times being selected indicates higher levels of discrimination experiences. Total score reported. Higher score means higher levels of discrimination. Total score can range from 0 - 68	12 months
Patient Health Questionnaire (PHQ) for Adults, PHQ-9	Measures depressive symptoms using the patient health questionnaire for adults. Questions are scored from 0-3, with lower scores indicating no/lower depressive symptoms. Total score can range from 0-27	12 months
Ideal Body Image	Measures patient perception of their current body image and their ideal body. image using a graphic scale ranging from 0-9, with 9 indicating higher levels of overweight/obesity.	12 months
Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise	30 questions to measure motivation to lose weight by examining three types of motivation. Scale ranges from 0-7 with 0 being "not at all" and 7 being "very true". A higher score indicates higher levels of motivation for diet and exercise habits. Total score can range from 0 - 210	12 months
NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support	16 questions to measure perceived levels of emotional support. Scale ranges from 1-5 with 1 being "never" and 5 being "always. A higher level score indicates higher level of emotional support. Total scores can range from 16-80	12 months

Collaborators and Investigators

• Sponsor: Ohio State University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2020
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Nutrition; minority; Health Coach; College Student
• Other Study ID Numbers: 2019B0560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No