Improving Cardiovascular Risk Factors in Black Young Adults

Not Applicable

Completed

Conditions: Obesity

Interventions: Behavioral: Smartphone + Text Messaging with Health Coach

Registration Number: NCT04412954

Lead Sponsor: Ohio State University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 256

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Smartphone + Text Messaging with Health Coach	Health coach with Smartphone application for diet and physical activity

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	Baseline to 12 months	Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)
Physical Activity-Active Minutes/Day	12 months	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
Physical Activity-Steps/Day	12 months	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.
Healthy Eating Index (HEI)	12 months	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.
Food Frequency Questionnaire (FFQ)	12 months	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

Secondary Outcome Measures

Name	Time	Method
Treatment Self-Regulation Questionnaire (TSRQ) for Diet and Exercise	12 months	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
NIH Patient Reported Outcome Measurement Information System (PROMIS) Measure for Emotional Support	12 months	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
Self-Efficacy for Exercise Scale	12 months	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.
Experiences of Discrimination Scale (EoD)	12 months	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
Rate of Participants Who Are Adherent to Self-Monitoring	Baseline to 12 months	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).
Dietary Self-Efficacy Scale (Diet-SE)	12 months	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.
Patient Health Questionnaire (PHQ) for Adults, PHQ-9	12 months	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
Ideal Body Image	12 months	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.