Tailor Made Intervention

Obesity Clinical Trial

Official title:

Tailored Made: Health Solutions (A su Medida: Soluciones Para su Salud)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04040335
• Other study ID #: 20181208
• Secondary ID: 1U54MD010722-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2020
• Source: University of Miami
• Contact: Neysari Arana, MPH
• Phone: 3052431327
• Email: narana[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to conduct a web based health intervention among Hispanic/Latino men. The program aims to increase physical activity, improve healthy eating practices, and reduce sedentary behavior among this population through behavior goal setting, tailored motivational messages, motivational interviewing and online small group sessions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 64 Years

Eligibility

Inclusion Criteria:

1. be age 35-64 at enrollment

2. identify as Latino or Hispanic

3. have a BMI of 27-50

4. be fluent in English or Spanish

5. provide an informed consent

6. weigh less than 400 pound

7. have access to a working cell phone or land-line phone

8. and access to reliable internet.

Exclusion Criteria:

1. Have a pre-existing condition that prohibits at least moderate physical activity

2. Have a serious medical condition that is likely to hinder accurate measurement of weight

3. Have a condition for which weight loss is contraindicated

4. Have a condition that would cause weight loss, prior or planned bariatric surgery

5. Chronic use of medications that are likely to cause weight gain or cause weight loss

6. No cell phone or land-line phone

7. No access to reliable internet

8. Participant is enrolled in another obesity, eating, or physical activity program or study

9. Psychiatric hospitalization in the past 12 months.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Tailor Made
Each small group session will last approximately 45 minutes and include provision of health education materials and activities that promote positive behavior change for a healthier lifestyle including information about activities that promote physical activity and healthy eating.
• Control
Participants will receive educational materials on health promotion topics and will be asked to review on their own.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in weight	Weight, in pounds, will be measured using a scale and the weight change at 3 months from baseline will be reported in absolute terms.	Baseline to week 12;
Primary	Percent change in weight	Weight will be measured using a scale and weight change percentage at 3 months from baseline will be reported.	Baseline to week 12;
Primary	Change in weight classification	Investigators will assess change in weight classification using BMI in kg/m^2 and report percentage of participants that regress from obese to overweight classification at 3 months from baseline.	Baseline to week 12;
Secondary	Change in eating practices measured by the Food, Attitudes and Behaviors Survey (FAB)	As measured by a modified version of the National Cancer Institute (NCI) 2007 Food Attitudes and Behaviors Survey, to measure the change in fruit and vegetable intake (FVI) during the past month. Responses will be converted into servings, as defined by the MyPyramid 1992 dietary guidelines. Total FVI will be calculated as the sum of all items on the screener, excluding fried potatoes.	Baseline to week 12; Baseline to week 24; Week 12 to week 24
Secondary	Change in physical activity measured by Global Physical Activity questionnaire (GPAQ)	The GPAQ measures time spent in vigorous and moderate intensity physical activity. A higher score equates to more physical activity. The range is from 0 - 150 minutes per week.	Baseline to week 12; Baseline to week 24; Week 12 to week 24
Secondary	Change in physical activity measured by fitbit	Data on physical activity will be collected using a fitbit device	Baseline to week 12