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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03913871
Other study ID # 2018-044-CTU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 29, 2018
Est. completion date January 11, 2019

Study information

Verified date May 2019
Source Tulane University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this pilot study is to test the feasibility and effectiveness of a mobile phone-based text messaging intervention to change the attitudes and eating behaviors of African American women residing in New Orleans, LA.


Description:

Design: The proposed study is a pre/post-test design where up to 60 female adult black/African Americans in Orleans and Jefferson Parish, Louisiana will be recruited to participated (Intervention, n=30; control n=30). If a woman is interested in participating, she will be asked to complete an evaluation/screen to determine if they are eligible for the study and asked to consent to participate. If a woman consents to participate they will be randomized to one of 2 groups:

1. Intervention group: Text messages to promote healthy eating: In this group, participants will receive personalized text messages to encourage healthy eating, specifically to increase consumption of fruits, vegetables and water; and a reduction in sugar sweetened beverages. They will receive some messages that will ask for a reply. They will receive an average of 1-2 messages per day for 4 weeks.

2. Control group: Control group participants will receive non-nutrition-related physical activity and general health/wellbeing text message. They will receive the text messages an average of 1-2 messages per day for 4 weeks

All participants will be asked to do the following tests that are not used to determine eligibility: Complete questionnaires about their background, nutrition habits, physical activity habits, health history, beliefs and opinions about health and habits. Data will be analyzed by comparing assessment outcomes within and across study arms (i.e., intervention, control).


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date January 11, 2019
Est. primary completion date January 11, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years and older
Eligibility Inclusion Criteria:

1. Age range: 25 years of age or older

2. Gender: Women

3. Ethnic background: African American or Black

4. Location: Orleans and Jefferson Parish, Louisiana

5. Own a mobile phone

6. Open to being assigned to either the intervention or control group.

7. Willing and able to use their phone to read, receive and send text messages and phone calls.

8. No overt cardiovascular disease or acute symptomatology. (self-reported).

Exclusion Criteria:

1. Age range: under 25 years of age

2. Ethnic background: not African American or Black

3. Location: Live outside of Orleans and Jefferson Parish, Louisiana

4. Does not own a mobile phone

5. Not open to being assigned to either the intervention or control group.

6. Unwilling and unable to use their phone to read, receive and send text messages and phone calls.

7. Overt cardiovascular disease or acute symptomatology. (self-reported).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Texts to support healthy eating
The intervention arm will receive tailored text messages to encourage healthy eating (increase consumption, fruits, vegetables and water; and a reduce intake of sugar sweetened beverages). Participants will receive an average of 1-2 messages per day for 4 weeks.
Texts to support physical activity
The intervention arm will receive tailored text messages to support increased minutes of physical activity per day. Participants will receive an average of 1-2 messages per day for 4 weeks.

Locations

Country Name City State
United States Jylana L. Sheats New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Tulane University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fruit and vegetable intake Change in fruit and vegetable intake from baseline to 4 weeks as measured by self-report via the NCI Fruit and Vegetable Intake Screener (from the Eating at America's Table Study). Scale Range: Frequency of intake (fruit, vegetable) - Never (minimum) to 5+ times per day (maximum); and Portion of fruit or vegetable (cup equivalents based on dietary guidelines). To score, 1) express each reported frequency as a daily average by standardizing the midpoint of each frequency category to the number of times per day; 2) assign fruit and vegetable servings from dietary guidelines to each portion size category; and 3) compute the average daily fruit and vegetable servings for each food group by multiplying the average daily frequency (from #1) by the number of servings for the portion size (as determined in #2). To estimate the total daily number of servings, sum across all food groups (i.e., fruit and vegetable subgroups). Baseline and 4 weeks
Primary Beverage intake Change in beverage intake intake from baseline to 4 weeks as measured by self-report via the (Beverage Intake Questionnaire-15 (BEVQ-15). Scale Range: Frequency of intake (of beverage option) - Never (minimum) to 3+ times per day (maximum); Consumption (of each beverage option)- Less than 6 fl. oz. (minimum) to more than 20 fl. oz (maximum). To score the instrument, frequency ("How often") is converted to the unit of times per day, then multiplied by the amount consumed ("How much each time") to provide average daily beverage consumption in fl oz. To quantify total SSB consumption, beverage categories containing added sugars were summed (sweetened juice beverages/drinks, regular soft drinks, sweet tea, sweetened coffee, energy drinks, mixed alcoholic drinks, meal replacement beverages). Baseline and 4 weeks
Secondary Self-efficacy to improve fruit and vegetable intake Self-efficacy for eating fruit and vegetables as measured by self report via the Self-efficacy for fruit and vegetable survey titled Fruits and Vegetables: Pros and Cons (Norman et al., 2010). The 6-item scale is scored from Not Important (minimum) to Extremely Important (maximum). Higher scores (summed) on this scale indicated higher frequency of using change strategies for healthy eating. Baseline and 4 weeks
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