Improving Cardiovascular Risk Factors in Black Young Adults

Obesity Clinical Trial

Official title:

Improving Cardiovascular Risk Factors in Black Young Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04412954
• Other study ID #: 2019B0560
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Body weight will be measured in light clothing without shoes using the Tanita Body Scale (BS)	Baseline to 12 months
Primary	Change in 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	Baseline to 12 months
Primary	Change in 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.	Baseline to 12 months
Primary	Food Frequency Questionnaire (FFQ) measuring change in eating habits	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.	Baseline to 12 months
Primary	Healthy Eating Index (HEI) measuring change in healthy eating score	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.	Baseline to 12 months
Secondary	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
Secondary	Change in 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 bring "very confident" Higher overall score indicates higher levels of self confidence.	Baseline to 12 months
Secondary	Change in 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.	Baseline to 12 months
Secondary	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.	Baseline to 12 months
Secondary	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.	Baseline to 12 months
Secondary	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.	Baseline to 12 months
Secondary	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	Baseline to 12 months
Secondary	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.	Baseline to 12 months