Addressing Place and People Micro Environments in Weight Loss Disparities
NCT ID: NCT03083964
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
350 participants
INTERVENTIONAL
2017-01-18
2021-12-11
Brief Summary
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Detailed Description
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At the end of the 2-4 week window, RAs will return to the home to collect the accelerometer and bite counter which takes about 1 hour. The accelerometer and bite counter are to be marked by the RA with the study participants ID and data are retrieved. At this time, participants who responded to 75% or more of the messages over the 2-4 week period, will be randomized to Usual Care (UC) or Priming Arm for Aim 2 and given instruction on the next steps of study participation. Randomization will be carried out within each race group to ensure a balance in the number of subjects between the two treatment arms. The Investigator will computer-generate randomization lists in field envelopes to be provided to the RAs for treatment assignment.
Aim 2: The second aim of the study will last 6 months. Both UC and Priming arms will have full access to Healthy-Me coaches and classes as well as receive training and access to the mHealth app. When study participation is excluded, all apps and associated data will be removed from the smartphone. At no time will Patient Health Information (PHI) be stored on the smartphone. Smartphones will only be identified by study ID number and the developer will only have access to the participants' study ID number and smartphone data collected by the mHealth app. Subjects in UC and Priming will undergo similar assessments and procedures; however, the Priming arm participants will, in addition receive 6-8 message alerts per day. The application and notifications that will be used in the Priming arm will be built from each participants own library to be delivered at times and in locations that their Aim 1 data indicate they often experience an eating or sedentary cue. In short, this intervention counters an obesogenic cue with a "healthy" prime in real-time and location.
Finally, following 6 months of UC or Priming, blinded RAs will return to participants home to complete 6-month follow-up assessment and collect all study related equipment. The final assessment and surveys will take about 1-1.5 hours and all data captured will also be carried out in REDCap.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Usual Care
Usual care involves a lifestyle coaching intervention delivered in primary care sites.
Usual Care
Usual care is not considered an intervention. This arm of the study involves a lifestyle coaching intervention delivered in primary care sites to the subjects.
Priming
Priming involves usual care plus just in time reminder messages related to mindful eating and physical activity.
Priming
The intervention is a just in time eating or physical activity reminder. Each individual participant reports physical activity goals as well as times that they most often eat. This information is used to select for that individual the best time to send an eating or physical activity reminder. The reminders come to the participant's smartphone or a study provided smartphone. Participants will receive reminder 2 to 4 times per day depending on their goals and behavior pattern.
Interventions
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Usual Care
Usual care is not considered an intervention. This arm of the study involves a lifestyle coaching intervention delivered in primary care sites to the subjects.
Priming
The intervention is a just in time eating or physical activity reminder. Each individual participant reports physical activity goals as well as times that they most often eat. This information is used to select for that individual the best time to send an eating or physical activity reminder. The reminders come to the participant's smartphone or a study provided smartphone. Participants will receive reminder 2 to 4 times per day depending on their goals and behavior pattern.
Eligibility Criteria
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Inclusion Criteria
1. Aged 35 to 64 years.
2. Female.
3. BMI ≥ 30.
4. Healthy-Me referral or Eligible for Healthy-Me
Self-reported Screener Data:
5. English as primary language.
6. Self-identified non-Hispanic black or African-American, or non-Hispanic white.
7. A permanent address.
Exclusion Criteria
1. Severe illness that might be associated with weight loss, such as cancer.
2. Use of weight loss medications (rare due to cost of the medications).
3. History of bipolar disorder or psychosis.
Self-reported Screener Data:
4. Severe cognitive impairment (≥3 errors on a 6-item cognitive screen).
5. Unwilling or unable to provide informed consent.
6. Bariatric surgery already completed or planned within 12 months.
7. Pregnant or nursing in past 6 months, or plans to become so within 12 months.
8. Residence outside of Marion County, Indiana.
9. Substance abuse (for alcohol; ≥2 on CAGE questionnaire).
10. Current smoking or tobacco use.
35 Years
64 Years
FEMALE
Yes
Sponsors
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Indiana University
OTHER
Responsible Party
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NiCole Keith
Professor, Department of Kinesiology
Locations
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Daniel Clark
Indianapolis, Indiana, United States
Countries
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References
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Clark DO, Keith NR, Ofner S, Hackett J, Li R, Agarwal N, Tu W. Environments and situations as correlates of eating and drinking among women living with obesity and urban poverty. Obes Sci Pract. 2021 Sep 1;8(2):153-163. doi: 10.1002/osp4.557. eCollection 2022 Apr.
Srinivas P, Bodke K, Ofner S, Keith NR, Tu W, Clark DO. Context-Sensitive Ecological Momentary Assessment: Application of User-Centered Design for Improving User Satisfaction and Engagement During Self-Report. JMIR Mhealth Uhealth. 2019 Apr 3;7(4):e10894. doi: 10.2196/10894.
Other Identifiers
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1512254890
Identifier Type: -
Identifier Source: org_study_id