Increasing Treatment for Obesity Among Underserved Populations

NCT05666323 | Completed

• 1 other identifier: HCI139694
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is to evaluate strategies to increase patient engagement in evidence-based interventions (EBIs) for obesity. The scientific premise of the proposed project is based on: 1) substantial evidence that EBIs for obesity are effective but grossly underutilized, 2) promising results indicating that technology-based approaches such as text messaging may increase the reach of EBIs among underserved populations, 3) data demonstrating that repeated offers of treatment can substantially increase enrollment even among patients who are initially unmotivated, and 4) prior research highlighting the effectiveness of Motivation And Problem Solving (MAPS), a proactive coaching approach used to address barriers to improve patient enrollment in EBIs. Thus, the proposed project will develop, implement, and evaluate two strategies for increasing the assessment and enrollment of University of Utah Medicaid patients in online EBIs for obesity: 1) Repeated offers of EBIs for obesity using text messaging and state of the science health communication strategies, 2) MAPS navigation/counseling among patients who do not enroll in EBIs in response to text messaging. The proposed project will provide critical data regarding the implementation of pragmatic and scalable interventions that are designed to increase the reach of existing EBIs for obesity among underserved populations. Most importantly, the project results lay the foundation for the widespread dissemination of strategies to increase use of EBIs for obesity across Utah, the Mountain West region, and the nation. Project deliverables include 1) a text messaging intervention for facilitating connection to EBIs for obesity; 2) MAPS intervention for facilitating connection to EBIs for obesity; 3) implementation, adaptation, and optimization of these interventions for University of Utah Medicaid patients, 4) preliminary evidence for the efficacy of these two interventions in improving the reach of EBIs for obesity, and 5) creation of a plan for further dissemination.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who were eligible, contacted, and enrolled in the trial.

  Proportion of participants who were eligible, contacted, and enrolled in the trial.

  at 12 weeks

Secondary Outcomes (4)

• Evidence-Based Intervention REACH Phase 1

  at 12 weeks

• Evidence-Based Intervention REACH Phase 2

  at 24 weeks

• Participant engagement with dissemination strategies

  at 24 weeks

• Evidence-Based Intervention Engagement

  at 12 weeks from enrollment

Study Arms (6)

Phase 1: TM1

EXPERIMENTAL

Patients in the TM1 condition will be randomized to receive either an autonomy supportive message, or a directive motivational message.

Behavioral: Single Text Messaging (TM1)

Phase 1: TM+

EXPERIMENTAL

Patients in the TM+ condition will be randomized to receive 5 text messages in scheduled succession. These messages will be either an autonomy supportive message, or a directive motivational message.

Behavioral: Multiple Text Messaging (TM+)

Phase 2: TM1 and PN

EXPERIMENTAL

Patients in the TM1 and PN condition will be randomized to receive either an autonomy supportive message, or a directive motivational message. Additionally, they will receive the option to talk with a Patient Navigator to receive MAPS coaching

Behavioral: Single Text Messaging (TM1); Behavioral: Patient Navigation (PN)

Phase 2: TM1 continued

EXPERIMENTAL

Patients in the TM1 continued arm have the continued option to reply to the first text message in "Phase 1: TM1." They do not receive any additional intervention.

Behavioral: Single Text Messaging (TM1)

Phase 2: TM+ and PN

EXPERIMENTAL

Patients in the TM+ and PN condition will be randomized to receive 3 additional either autonomy supportive messages, or directive motivational messages. Additionally, they will receive the option to talk with a Patient Navigator to receive MAPS coaching

Behavioral: Patient Navigation (PN); Behavioral: Multiple Text Messaging (TM+)

Phase 2: TM+ continued

EXPERIMENTAL

Patients in TM+ continued will receive 3 additional either autonomy supportive messages, or directive motivational messages.

Behavioral: Multiple Text Messaging (TM+)

Interventions

Single Text Messaging (TM1) BEHAVIORAL

Receives single text message

Phase 1: TM1; Phase 2: TM1 and PN; Phase 2: TM1 continued

Patient Navigation (PN) BEHAVIORAL

Receive phone calls from trained MAPS counselors

Phase 2: TM+ and PN; Phase 2: TM1 and PN

Multiple Text Messaging (TM+) BEHAVIORAL

Receives multiple scheduled text messages

Phase 1: TM+; Phase 2: TM+ and PN; Phase 2: TM+ continued

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be adults aged 18+
• have a BMI of 30 or higher
• have had a primary care appointment within University of Utah Health within the past year
• speak English or Spanish as their primary language
• have a current Utah address
• are insured through Medicaid (University of Utah Health Plans).

You may not qualify if:

• patients may not have a diagnosis of Type 1 or Type 2 Diabetes
• being currently pregnant

Sponsors & Collaborators

• University of Utah: lead
• Ben B & Iris Margolis Private Foundation for Medical Research: collaborator

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Schlechter CR, Del Fiol G, Jones DR, Orleans B, Gibson B, Nahum-Shani I, Maxfield E, Locke A, Cornia R, Bradshaw R, Wirth J, Jaggers SJ, Lam CY, Wetter DW. Increasing the reach of evidence-based interventions for weight management and diabetes prevention among Medicaid patients: study protocol for a pilot Sequential Multiple Assignment Randomised Trial. BMJ Open. 2023 Nov 27;13(11):e075157. doi: 10.1136/bmjopen-2023-075157.

  PMID: 38011967 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

TM 1; Patient Navigation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• David Wetter, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: This study will use a Sequential Multiple Assignment Randomized Trial (SMART) Design, which will allow investigators to address questions like those of traditional factorial design and assess dynamic treatment regimens to inform the development of adaptive interventions. An adaptive intervention contains a sequence of individually tailored decision rules that specify the intensity or type of intervention at critical points in the delivery of care. Modifying intensity or type of intervention over time can improve outcomes if an individual is not responding, or may reduce costs and patient burden if more resource intensive treatment is not necessary. As such, the proposed SMART design informs the development of adaptive and stepped care interventions, and the reduction in patient burden is particularly important to ensure that the interventions are as patient centered as possible.

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: March 23, 2022
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)