HyperlipemiaNCT04382521
A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions
A study testing Text Message Intervention in people with Hyperlipemia and Hypertension, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipemia, Hypertension, Type2 Diabetes
- What is being tested?
- Text Message Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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).
Read the 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
- Being tested
- Text Message Intervention
- Keywords
- text message intervention, health behavior change, positive psychology
- Medical subject headings
- Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Text Message Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of messages correctly delivered
Proportion of adaptive TMI messages correctly selected/sent will be included as a measure of feasibility.
Measured: 12 weeks
Rates of feedback to individual text messages
Rates of feedback to individual text messages will be included as a measure of feasibility.
Measured: 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
Measured: 12 weeks
Secondary outcomes (15)
Change in Positive and Negative Affect Schedule (PANAS) Score
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Higher scores indicate higher levels of positive affect. The measure will be used at baseline, 12 weeks and 24 weeks.
Measured: Baseline, 12 weeks and 24 weeks
Change in Life Orientation Test-Revised Score
Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Higher scores indicate higher levels of optimism. The measure will be used at baseline, 12 weeks and 24 weeks.
Measured: Baseline, 12 weeks and 24 weeks
Change in General Self-Efficacy Scale score
The General Self-Efficacy Scale is a self-report measure of self-efficacy. The total score ranges from 10-40, with a higher score indicating more self-efficacy.
Measured: Baseline, 12 weeks and 24 weeks
Change in HADS-A Score
The anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound anxiety assessment in medically-ill patients. (Range: 0-21) Higher scores indicate higher levels of anxiety. The measure will be used at baseline, 12 weeks, and 24 weeks.
Measured: Baseline, 12 weeks and 24 weeks
Change in HADS-D Score
The depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood assessment in medically-ill patients.(Range: 0-21). Higher scores indicate worse outcome (i.e. greater levels of depression). The measure will be used at baseline, 12 weeks, and 24 weeks.
Measured: Baseline, 12 weeks and 24 weeks
Change in Multidimensional Health Locus of Control Score
This is an 18-item instrument that measures three dimensions of locus of control. It assesses people's beliefs that their health is or is not determined by their own behavior. The survey has three subscales: internality of health locus of control, powerful other locus of control, and chance locus of control. All items are measured on a 6-point Likert scale, and our main subscale of interest will be internal locus of control, which will be a sum of scores from questions 1,6,8,12,13,17 (range: 6-36). Higher scores indicate higher locus of control.
Measured: Baseline, 12 weeks and 24 weeks
Change in Multidimensional Scale of Perceived Social Support Score
The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other. It is rated on a 7-point likert scale, ranging from 1 "very strongly disagree" to 7 "very strongly agree." Each subscale score can range from 4 to 28. Items are summed, and a total score is also calculated and ranges from 12 to 84. Higher subscale and total scores indicate high levels of perceived social support.
Measured: Baseline, 12 weeks and 24 weeks
Change in MEDFICTS score
MEDFICTS is a screening instrument for dietary fat to assess adherence to the Adult Treatment Panel (ATP) III Therapeutic Lifestyle Changes (TLC) diet. The test measures the intake of meats, eggs, dairy, fried foods, fats in baked goods, convenience foods, table fats, and snacks. Higher scores indicate higher fat consumption.
Measured: Baseline, 12 weeks and 24 weeks
Change in Behavioral Risk Factor Surveillance System [BRFSS] Fruit and Vegetable Consumption Module
The CDC's BRFSS Fruit and Vegetable Module is a brief questionnaire about frequency of eating different types of fruits and vegetables. It assesses the frequency of consumption of 100% fruit juice, fruit, beans (legumes), dark green vegetables, orange vegetables, and other vegetables over the past month. The outcome measure is the number of fruits or vegetables consumed per day.
Measured: Baseline, 12 weeks and 24 weeks
Change in Moderate to vigorous physical activity (minutes) measured via accelerometer
Measured by Actigraph accelerometer, in minutes per day.
Measured: Baseline, 12 weeks and 24 weeks
Change in physical activity (steps) measured via accelerometer
Measured by Actigraph accelerometer, in number of steps per day.
Measured: Baseline, 12 weeks and 24 weeks
Change in sedentary time measured via accelerometer
Measured by Actigraph accelerometer, in minutes per day.
Measured: Baseline, 12 weeks and 24 weeks
Change in self-report physical activity time measured by International Physical Activity Questionnaire
Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assess the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. The measure will be used at baseline, 12 weeks, and 24 weeks.
Measured: Baseline, 12 weeks and 24 weeks
Change in physical function measured by PROMIS 20-item
Measured by the 20-item short form of the Patient-Reported Outcomes Measurement Information System (PROMIS), a well-validated measure of physical function that is highly responsive to changes in a patient's physical function status (Range: 20-100). Higher scores indicate better physical function.
Measured: Baseline, 12 weeks and 24 weeks
Change in physical function measured by 6-minute test
The 6-minute walk test is a test to measure participant's functional capacity, assessing distance walked in meters in 6 minutes.
Measured: Baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start22 Sep 2020
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipemiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382521
- Sponsor's protocol ID
- 2019P003495
- Status last verified
- Jul 2023
- First submitted
- 25 Apr 2020
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38171212
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions
- ClinicalTrials.gov ID
- NCT04382521
- Acronym / sponsor ID
- 2019P003495
- Conditions
- Hyperlipemia, Hypertension, Type2 Diabetes
- Keywords
- text message intervention, health behavior change, positive psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Message Intervention (TMI) | Experimental | Behavioral: Text Message InterventionParticipants 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. |
| Wait-list Control Group (WLC) | Other | Behavioral: Text Message InterventionWaitlist 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Message InterventionParticipants 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. | Behavioural | Text Message Intervention (TMI), Wait-list Control Group (WLC) |
Primary outcome
Proportion of messages correctly delivered
Time frame: 12 weeks
Proportion of adaptive TMI messages correctly selected/sent will be included as a measure of feasibility.
Rates of feedback to individual text messages
Time frame: 12 weeks
Rates of feedback to individual text messages will be included as a measure of feasibility.
Participant's mean ratings of message utility to measure acceptability of the text-message intervention
Time frame: 12 weeks
0-10 Likert scale score regarding the utility of that day's text message
15 secondary outcomes
Change in Positive and Negative Affect Schedule (PANAS) Score
Time frame: Baseline, 12 weeks and 24 weeks
Change in Life Orientation Test-Revised Score
Time frame: Baseline, 12 weeks and 24 weeks
Change in General Self-Efficacy Scale score
Time frame: Baseline, 12 weeks and 24 weeks
Change in HADS-A Score
Time frame: Baseline, 12 weeks and 24 weeks
Change in HADS-D Score
Time frame: Baseline, 12 weeks and 24 weeks
Change in Multidimensional Health Locus of Control Score
Time frame: Baseline, 12 weeks and 24 weeks
Change in Multidimensional Scale of Perceived Social Support Score
Time frame: Baseline, 12 weeks and 24 weeks
Change in MEDFICTS score
Time frame: Baseline, 12 weeks and 24 weeks
Change in Behavioral Risk Factor Surveillance System [BRFSS] Fruit and Vegetable Consumption Module
Time frame: Baseline, 12 weeks and 24 weeks
Change in Moderate to vigorous physical activity (minutes) measured via accelerometer
Time frame: Baseline, 12 weeks and 24 weeks
Change in physical activity (steps) measured via accelerometer
Time frame: Baseline, 12 weeks and 24 weeks
Change in sedentary time measured via accelerometer
Time frame: Baseline, 12 weeks and 24 weeks
Change in self-report physical activity time measured by International Physical Activity Questionnaire
Time frame: Baseline, 12 weeks and 24 weeks
Change in physical function measured by PROMIS 20-item
Time frame: Baseline, 12 weeks and 24 weeks
Change in physical function measured by 6-minute test
Time frame: Baseline, 12 weeks and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 38171212Celano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message Intervention in people with Hyperlipemia and Hypertension, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of messages correctly delivered (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.