Addressing Place and People Micro Environments in Weight Loss Disparities

NCT03083964 | Completed

• 1 other identifier: 1512254890
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to A) capture obesogenic cues that occur in daily life, and B) to deliver cue alerts. Investigators hypothesized that A) black women experience more cues, B) racial disparities in obesity are reduced in models that adjust for cues, and C) the priming arm will achieve a weight loss of 2kg or more. Investigators will explore whether racial disparities in weight loss differ between the groups receiving usual care or those receiving cues.

Conditions

Obese

Keywords

Middle aged women; 35-64yrs; BMI= >30

Outcome Measures

Primary Outcomes (1)

• Proportion of participants that lose 2 kilograms of weight between baseline and 6 month follow-up

  Participants are weighed at baseline and 6 months to access if proportion is losing 2kg of body weight or more by 6 months.

  baseline and 6 months

Secondary Outcomes (4)

• Physical activity frequency

  6 months

• Eating Frequency

  6months

• Depression

  6 months

• Anxiety

  6 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual care involves a lifestyle coaching intervention delivered in primary care sites.

Behavioral: Usual Care

Priming

EXPERIMENTAL

Priming involves usual care plus just in time reminder messages related to mindful eating and physical activity.

Behavioral: Priming

Interventions

Usual Care BEHAVIORAL

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.

Usual Care

Priming BEHAVIORAL

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.

Priming

Eligibility Criteria

• Age: 35 Years - 64 Years
• Gender Eligibility Details: Enrolling females to capture obesogenic cues as they occur in daily life among 150 obese black and 150 obese white women ages 35-64 years who have received an FQHC provider referral to the Healthy Me weight management program.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Electronic Screener Data (EMR):
• Aged 35 to 64 years.
• Female.
• BMI ≥ 30.
• Healthy-Me referral or Eligible for Healthy-Me
• Self-reported Screener Data:
• English as primary language.
• Self-identified non-Hispanic black or African-American, or non-Hispanic white.
• A permanent address.

You may not qualify if:

• Electronic Screener Data (EMR):
• Severe illness that might be associated with weight loss, such as cancer.
• Use of weight loss medications (rare due to cost of the medications).
• History of bipolar disorder or psychosis.
• Self-reported Screener Data:
• Severe cognitive impairment (≥3 errors on a 6-item cognitive screen).
• Unwilling or unable to provide informed consent.
• Bariatric surgery already completed or planned within 12 months.
• Pregnant or nursing in past 6 months, or plans to become so within 12 months.
• Residence outside of Marion County, Indiana.
• Substance abuse (for alcohol; ≥2 on CAGE questionnaire).
• Current smoking or tobacco use.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Daniel Clark

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• 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.

  PMID: 35388340 DERIVED

• 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.

  PMID: 30942698 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcome assessor is blind to study assignment and investigators do not have access to randomization records.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Kinesiology

Model Details: The participants are randomized to one of two treatment arms, usual care or intervention.

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: March 20, 2017
• Study Start: January 18, 2017
• Primary Completion: December 11, 2021
• Study Completion: December 11, 2021
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)