- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03913871
Text Message Program to Improve Eating Behaviors Among African Americans in New Orleans
Study Overview
Status
Intervention / Treatment
Detailed 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:
- 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.
- 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Jylana L. Sheats
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age range: 25 years of age or older
- Gender: Women
- Ethnic background: African American or Black
- Location: Orleans and Jefferson Parish, Louisiana
- Own a mobile phone
- Open to being assigned to either the intervention or control group.
- Willing and able to use their phone to read, receive and send text messages and phone calls.
- No overt cardiovascular disease or acute symptomatology. (self-reported).
Exclusion Criteria:
- Age range: under 25 years of age
- Ethnic background: not African American or Black
- Location: Live outside of Orleans and Jefferson Parish, Louisiana
- Does not own a mobile phone
- Not open to being assigned to either the intervention or control group.
- Unwilling and unable to use their phone to read, receive and send text messages and phone calls.
- Overt cardiovascular disease or acute symptomatology. (self-reported).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Telephone (text messages) support for healthy eating
Participants will receive average of 1-2 text messages per day for 4 weeks focused on health eating with the aim increasing consumption of fruits, vegetables and water; and a reduce intake of sugar sweetened beverages.
|
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.
|
|
Active Comparator: Telephone (text messages) support for physical activity
Participants will receive an average of 1-2 text messages per day for 4 weeks that offer physical activity and general health/wellbeing advice.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fruit and vegetable intake
Time Frame: Baseline and 4 weeks
|
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
|
|
Beverage intake
Time Frame: Baseline and 4 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy to improve fruit and vegetable intake
Time Frame: Baseline and 4 weeks
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-044-CTU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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