Diet HabitNCT03913871
Text Message Program to Improve Eating Behaviors Among African Americans in New Orleans
A study testing Texts to support healthy eating and Texts to support physical activity in people with Diet Habit and Health Behavior, run by Tulane University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet Habit, Health Behavior, Health Knowledge, Attitudes, Practice
- What is being tested?
- Texts to support healthy eating and Texts to support physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 11 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- Texts to support healthy eating, Texts to support physical activity
- Keywords
- mHealth, African American, Women's Health, Minority Health
- Medical subject headings
- Feeding Behavior, Health Behavior, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Texts to support healthy eatingBehavioural
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 activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telephone (text messages) support for healthy eating | Experimental | 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. Receives: Behavioral: Texts to support healthy eating |
| Telephone (text messages) support for physical activity | Active comparator | Participants will receive an average of 1-2 text messages per day for 4 weeks that offer physical activity and general health/wellbeing advice. Receives: Behavioral: Texts to support physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 4 weeks
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).
Measured: Baseline and 4 weeks
Secondary outcomes (1)
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start29 Oct 2018
- Primary completion11 Jan 2019
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jylana L. Sheats, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913871
- Sponsor's protocol ID
- 2018-044-CTU
- Status last verified
- May 2019
- First submitted
- 16 Aug 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Message Program to Improve Eating Behaviors Among African Americans in New Orleans
- ClinicalTrials.gov ID
- NCT03913871
- Acronym / sponsor ID
- 2018-044-CTU
- Keywords
- mHealth, African American, Women's Health, Minority Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telephone (text messages) support for healthy eating | Experimental | Behavioral: Texts to support healthy eatingParticipants 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. |
| Telephone (text messages) support for physical activity | Active comparator | Behavioral: Texts to support physical activityParticipants will receive an average of 1-2 text messages per day for 4 weeks that offer physical activity and general health/wellbeing advice. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Texts to support healthy eatingThe 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. | Behavioural | Telephone (text messages) support for healthy eating |
| Texts to support physical activityThe 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. | Behavioural | Telephone (text messages) support for physical activity |
Primary outcome
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).
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).
1 secondary outcome
Self-efficacy to improve fruit and vegetable intake
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Texts to support healthy eating and Texts to support physical activity in people with Diet Habit and Health Behavior, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fruit and vegetable intake (time frame: Baseline and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.