Text Message Program to Improve Eating Behaviors Among African Americans in New Orleans

Sponsor
Tulane University (Other)
Overall Status
Completed
CT.gov ID
NCT03913871
Collaborator
(none)
44
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2
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Texts to support healthy eating
  • Behavioral: Texts to support physical activity
N/A

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:

  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).

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This was a clinical trial (behavioral with no clinical assessments) in which two groups of participants receive different interventions. One group received a healthy eating program, and the other group received a physical activity program.This was a clinical trial (behavioral with no clinical assessments) in which two groups of participants receive different interventions. One group received a healthy eating program, and the other group received a physical activity program.
Masking:
Single (Participant)
Masking Description:
An online randomizer software was used to assign participants into one of two arms.
Primary Purpose:
Prevention
Official Title:
Text Message Program to Improve Eating Behaviors Among African Americans in New Orleans
Actual Study Start Date :
Oct 29, 2018
Actual Primary Completion Date :
Jan 11, 2019
Actual Study Completion Date :
Jan 11, 2019

Arms and Interventions

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.

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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Fruit and vegetable intake [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).

  2. Beverage intake [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).

Secondary Outcome Measures

  1. Self-efficacy to improve fruit and vegetable intake [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jylana L. Sheats New Orleans Louisiana United States 70112

Sponsors and Collaborators

  • Tulane University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jylana L. Sheats, Assistant Professor, Tulane University
ClinicalTrials.gov Identifier:
NCT03913871
Other Study ID Numbers:
  • 2018-044-CTU
First Posted:
Apr 12, 2019
Last Update Posted:
May 7, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jylana L. Sheats, Assistant Professor, Tulane University

Study Results

No Results Posted as of May 7, 2019