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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913871
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jylana L. Sheats, Tulane University

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
Diet Habit Health Behavior Health Knowledge, Attitudes, Practice Behavioral: Texts to support healthy eating Behavioral: Texts to support physical activity Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
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.
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 : October 29, 2018
Actual Primary Completion Date : January 11, 2019
Actual Study Completion Date : January 11, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility based on self-representation of gender identity.
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913871


Locations
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United States, Louisiana
Jylana L. Sheats
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Tulane University

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Responsible Party: Jylana L. Sheats, Assistant Professor, Tulane University
ClinicalTrials.gov Identifier: NCT03913871    
Other Study ID Numbers: 2018-044-CTU
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jylana L. Sheats, Tulane University:
mHealth
African American
Women's Health
Minority Health