A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions

NCT ID: NCT04382521

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2023-04-15

Brief Summary

This is a randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of an adaptive text message intervention (TMI) to promote well-being and health behavior adherence in 60 patients with two or more cardiac risk conditions (hypertension, type 2 diabetes, or hyperlipidemia).

Detailed Description

The investigators have developed an adaptive text message intervention (TMI) that uses participant feedback for individual messages and progress towards health goals to deliver increasingly personalized positive psychology (PP) and health behavior text messages over time. The investigators aim to examine its feasibility, acceptability, and preliminary efficacy in a randomized, controlled pilot trial in 60 adults with two or more cardiac risk conditions (hypertension, type 2 diabetes, or hyperlipidemia).

Conditions

Hyperlipemia; Hypertension; Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Text Message Intervention (TMI)

Participants in the TMI condition will receive daily text messages through an adaptive algorithm plus separate twice-weekly tailored messages focused on a specific health goal.

Group Type: EXPERIMENTAL

Text Message Intervention

Intervention Type: BEHAVIORAL

Participants will undergo a three component intervention consisting of (1) daily, adaptive text messages related to Positive Psychology or health behaviors, (2) twice weekly text messages related to a specific health behavior goal, and (3) three brief check-ins (at baseline, week 4, and week 8 of the intervention) with a study staff member to discuss progress towards health behavior goals. During the brief check-ins, the study staff member will inquire about: (1) medical conditions, (2) adherence gaps, (3) personal health goals (including weight goals), (4) motivation, self-efficacy, and barriers to reaching health goals, (5) preferred activity types (e.g., walking), and (6) sources of sedentary time (e.g., computer, TV). This information will be added to the algorithm for each individual and we will deliver tailored daily text messages for our participants.

Wait-list Control Group (WLC)

Waitlist Control group participants will begin to receive the full 12-week Text Message Intervention (with all components, e.g., phone check-ins) after completing follow-up assessments at Weeks 12 and 24. Participants in this group will receive no text messages or other study-specific interventions during the first 24 weeks of the study.

Group Type: OTHER

Text Message Intervention

Intervention Type: BEHAVIORAL

Participants will undergo a three component intervention consisting of (1) daily, adaptive text messages related to Positive Psychology or health behaviors, (2) twice weekly text messages related to a specific health behavior goal, and (3) three brief check-ins (at baseline, week 4, and week 8 of the intervention) with a study staff member to discuss progress towards health behavior goals. During the brief check-ins, the study staff member will inquire about: (1) medical conditions, (2) adherence gaps, (3) personal health goals (including weight goals), (4) motivation, self-efficacy, and barriers to reaching health goals, (5) preferred activity types (e.g., walking), and (6) sources of sedentary time (e.g., computer, TV). This information will be added to the algorithm for each individual and we will deliver tailored daily text messages for our participants.

Interventions

Text Message Intervention

Participants will undergo a three component intervention consisting of (1) daily, adaptive text messages related to Positive Psychology or health behaviors, (2) twice weekly text messages related to a specific health behavior goal, and (3) three brief check-ins (at baseline, week 4, and week 8 of the intervention) with a study staff member to discuss progress towards health behavior goals. During the brief check-ins, the study staff member will inquire about: (1) medical conditions, (2) adherence gaps, (3) personal health goals (including weight goals), (4) motivation, self-efficacy, and barriers to reaching health goals, (5) preferred activity types (e.g., walking), and (6) sources of sedentary time (e.g., computer, TV). This information will be added to the algorithm for each individual and we will deliver tailored daily text messages for our participants.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Cardiac risk conditions. Participants will have two or more of hypertension, type-2 diabetes, and hyperlipidemia. Patients will have met 2+ of 2017 AHA-ACC criteria for hypertension (SBP ≥130, DBP ≥80), 2018 ADA criteria for type-2 diabetes (e.g., A1C ≥6.5%), and 2013 AHA-ACC criteria for hyperlipidemia (e.g., LDL cholesterol ≥190), via medical record review, with confirmation by healthcare providers as needed.
• Low physical activity or elevated sedentary leisure time (SLT). Low activity will be defined as ≤150 minutes/week of moderate to vigorous activity (MVPA), which is an ADA-recommended level of MVPA; elevated SLT will be ≥120 min/day, which is linked to adverse medical health. As initial screens for both MVPA and SLT, we will use the International Physical Activity Questionnaire (IPAQ). Patients reporting ≤150 min/week of MVPA or ≥120 min/day of SLT will wear accelerometers for 10 days to confirm low MVPA/high SLT (patients will indicate their leisure time hours to allow assessment of SLT during those hours).
• Suboptimal diet. Participants must also report either fewer than 5 daily servings of fruit/vegetables (measured by the Behavioral Risk Factor Surveillance System's [BRFSS] Fruit and Vegetable Consumption Module) or have a score of ≥70 on the MEDFICTS scale for fat/cholesterol intake, representing high risk. We will require diet and activity deficits to ensure that a broad range of messages will be relevant to every participant as we explore the utility of individual messages and patterns of message selection in this initial study.
• Ability to receive text messages. Participants must have a cellular phone that receives texts and that they use at least daily. We will remunerate them the cost of receiving the messages as needed.
• Ability to read in English or Spanish. Text messages will be available in English and Spanish.

Exclusion Criteria

• Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).
• An unrelated condition limiting physical activity.
• Participation in programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).
• A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen designed to assess suitability for research participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeff C. Huffman, MD

Director of Cardiac Psychiatry Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Celano CM, Healy BC, Jacobson LH, Bell M, Carrillo A, Massey CN, Chung WJ, Legler SR, Huffman JC. An adaptive text message intervention to promote psychological well-being and reduce cardiac risk: The Text4Health controlled clinical pilot trial. J Psychosom Res. 2024 Feb;177:111583. doi: 10.1016/j.jpsychores.2023.111583. Epub 2023 Dec 30.

Reference Type: DERIVED

PMID: 38171212 (View on PubMed)

Other Identifiers

2019P003495

Identifier Type: -

Identifier Source: org_study_id