Improving Cardiovascular Risk Factors in Black Young Adults

NCT04412954 | Completed Results DMC

• 1 other identifier: 2019B0560
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

minority; College Student; Nutrition; Physical Activity; Health Coach

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Rate of Participants Who Are Adherent to Self-Monitoring

  Baseline to 12 months

• Dietary Self-Efficacy Scale (Diet-SE)

  12 months

• Self-Efficacy for Exercise Scale

  12 months

• Experiences of Discrimination Scale (EoD)

  12 months

• Patient Health Questionnaire (PHQ) for Adults, PHQ-9

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Health coach with Smartphone application for diet and physical activity

Behavioral: Smartphone + Text Messaging with Health Coach

Control

NO INTERVENTION

No intervention, using a Smartphone application for sleep monitoring

Interventions

Smartphone + Text Messaging with Health Coach BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• 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.

  PMID: 36070664 DERIVED

• 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.

  PMID: 34389927 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

Limitations of this trial include being conducted at a single site, being limited to those who are aged 17-25 years, and being limited to those who own smartphones or devices. Additional limitations include unpredictability of health coaches in terms of messaging patients on time.

Results Point of Contact

• Title: Sandy Solove
• Organization: Ohio State Univeristy

solove.3@osu.edu

6142478366

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 2, 2020
• Study Start: December 5, 2020
• Primary Completion: January 1, 2024
• Study Completion: November 30, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)