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

NCT04382521 | Completed

• 1 other identifier: 2019P003495
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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).

Conditions

Hyperlipemia; Hypertension; Type2 Diabetes

Keywords

text message intervention; health behavior change; positive psychology

Outcome Measures

Primary Outcomes (3)

• Proportion of messages correctly delivered

  Proportion of adaptive TMI messages correctly selected/sent will be included as a measure of feasibility.

  12 weeks

• Rates of feedback to individual text messages

  Rates of feedback to individual text messages will be included as a measure of feasibility.

  12 weeks

• Participant's mean ratings of message utility to measure acceptability of the text-message intervention

  0-10 Likert scale score regarding the utility of that day's text message

  12 weeks

Secondary Outcomes (15)

• Change in Positive and Negative Affect Schedule (PANAS) Score

  Baseline, 12 weeks and 24 weeks

• Change in Life Orientation Test-Revised Score

  Baseline, 12 weeks and 24 weeks

• Change in General Self-Efficacy Scale score

  Baseline, 12 weeks and 24 weeks

• Change in HADS-A Score

  Baseline, 12 weeks and 24 weeks

• Change in HADS-D Score

  Baseline, 12 weeks and 24 weeks

Study Arms (2)

Text Message Intervention (TMI)

EXPERIMENTAL

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.

Behavioral: Text Message Intervention

Wait-list Control Group (WLC)

OTHER

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.

Behavioral: Text Message Intervention

Interventions

Text Message Intervention 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.

Text Message Intervention (TMI); Wait-list Control Group (WLC)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 38171212 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Hypertension

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac Psychiatry Research Program

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: May 11, 2020
• Study Start: September 22, 2020
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)