NCT03913871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

August 16, 2018

Last Update Submit

May 3, 2019

Conditions

Keywords

mHealthAfrican AmericanWomen's HealthMinority Health

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Self-efficacy to improve fruit and vegetable intake

    Baseline and 4 weeks

Study Arms (2)

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.

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.

Behavioral: Texts to support physical activity

Interventions

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.

Telephone (text messages) support for healthy eating

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.

Telephone (text messages) support for physical activity

Eligibility Criteria

Age25 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jylana L. Sheats

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Feeding BehaviorHealth BehaviorBehavior

Condition Hierarchy (Ancestors)

Behavior, Animal

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
An online randomizer software was used to assign participants into one of two arms.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 16, 2018

First Posted

April 12, 2019

Study Start

October 29, 2018

Primary Completion

January 11, 2019

Study Completion

January 11, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations