ObesityNCT03203655
Text Based Mobile Technology and Weight Loss
A study testing CareMessage™ in people with Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Hispanic populations in the US are dis-proportionally affected by high rates of obesity and diabetes; according to the Centers for Disease Control and Prevention, Latinos are the minority group with the second-highest obesity prevalence in adults. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- CareMessage™
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 31 Jan 2019
- 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 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participants with a history of and/or current mental or physical disabilities.
- Participants with BMI over 45
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63105
About this study
Official title: Efficacy of a Culturally Sensitive and Linguistically Appropriate Internet and Mobile-based Weight Loss Therapy in Obese Hispanic/Latino Adult Women
Hispanic populations in the US are dis-proportionally affected by high rates of obesity and diabetes; according to the Centers for Disease Control and Prevention, Latinos are the minority group with the second-highest obesity prevalence in adults. In comparison to the general female population (61.2%), Mexican American women (73%) have a greater overweight or obese percentage. In addition, more than 50% of Hispanic men and women are expected to develop type-2 diabetes over their lifetime, compared to 40% among whites. Hispanics are also 50% more likely to die from diabetes compared to whites. In many cases Hispanic populations do not have the knowledge, self-confidence and resources to participate in mainstream physical activity and nutrition interventions, which are usually geared towards the general population without considering cultural and linguistic differences.
Information and communication technologies in the form of Internet and mobile phone access have grown enormously during the past decade; these technologies have the potential to affect food intake and physical activity as well as weight loss. Approximately 95% of countries have mobile telephone networks and about 70% of people worldwide use mobile phones.
Read more
CareMessage is a Google-backed 501(c)3 nonprofit technology organization based in San Francisco that uses 'smart' text and voice messaging to enable clinical staff to provide automated yet personalized support to patients struggling with chronic conditions. The CareMessage™ Adult Obesity texting program adapts the Health Belief Model by strategically implementing behavioral concepts to help improve self-efficacy.
The investigators will pilot test its effectiveness among a sample of Hispanic women who are at risk of obesity and diabetes by sending a culturally-sensitive and linguistically-appropriate text-based message three to 5 times a week, encouraging lifestyle modifications (diet and exercise education and behavior modification).
Read the detailed description
The investigators will collect data on 40 obese (Body Mass Index 30-45) Hispanic women ages 21 to 65 years. The purpose of this research study is to test the efficacy of a mobile phone text message-based intervention on weight loss.
After verifying eligibility and enrolling in the study, participants will come to Washington University School of Medicine, at Barnes-Jewish Hospital and fill out some questionnaires. The investigators will perform a brief exam that measures the lean and fat tissue using Dual Energy x-ray Absorptiometry (DXA) technology and will also do a modified 3-hour oral glucose tolerance test (MOGTT).
Participants will wear an accelerometer (activity monitor) over a 7-day period at the beginning (before being randomized and enrolled in the intervention) and at the end of the study.
Half of the participants will be randomized to the intervention group. The intervention group will be enrolled in the CareMessage™ Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss. The control group will receive an initial talk about weight loss but will not be enrolled in any program or intervention.
After six months have passed, participants will return to Washington University School of Medicine, regardless of the group they were assigned to, for two final visits (a short one, to pick up another activity monitor seven days before the study ends, and a longer visit, to do some final testing and fill out some questionnaires).
- Conditions
- Obesity
- Being tested
- CareMessage™, Control Condition
- Keywords
- Mobile text, Obesity, Hispanic, Women
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareMessage™Behavioural
Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss.
Control ConditionBehavioural
Control condition will receive an initial talk about weight loss but will not be enrolled in any program or intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group will be enrolled in the CareMessage™ Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss. Receives: Behavioral: CareMessage™ |
| Control Group | Other | The control group will receive the control condition. They will hear an initial talk about weight loss but will not be enrolled in any program or intervention. Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass Index
is a measure of body fat based on height and weight that applies to adult men and women.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start27 Nov 2017
- Primary completion25 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Parra, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203655
- Sponsor's protocol ID
- 201704048
- Status last verified
- Feb 2019
- First submitted
- 28 Jun 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Culturally Sensitive and Linguistically Appropriate Internet and Mobile-based Weight Loss Therapy in Obese Hispanic/Latino Adult Women
- ClinicalTrials.gov ID
- NCT03203655
- Acronym / sponsor ID
- 201704048
- Conditions
- Obesity
- Keywords
- Mobile text, Obesity, Hispanic, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 29 Jun 2017 (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.
Hispanic populations in the US are dis-proportionally affected by high rates of obesity and diabetes; according to the Centers for Disease Control and Prevention, Latinos are the minority group with the second-highest obesity prevalence in adults. In comparison to the general female population (61.2%), Mexican American women (73%) have a greater overweight or obese percentage. In addition, more than 50% of Hispanic men and women are expected to develop type-2 diabetes over their lifetime, compared to 40% among whites. Hispanics are also 50% more likely to die from diabetes compared to whites. In many cases Hispanic populations do not have the knowledge, self-confidence and resources to participate in mainstream physical activity and nutrition interventions, which are usually geared towards the general population without considering cultural and linguistic differences.
Information and communication technologies in the form of Internet and mobile phone access have grown enormously during the past decade; these technologies have the potential to affect food intake and physical activity as well as weight loss. Approximately 95% of countries have mobile telephone networks and about 70% of people worldwide use mobile phones.
CareMessage is a Google-backed 501(c)3 nonprofit technology organization based in San Francisco that uses 'smart' text and voice messaging to enable clinical staff to provide automated yet personalized support to patients struggling with chronic conditions. The CareMessage™ Adult Obesity texting program adapts the Health Belief Model by strategically implementing behavioral concepts to help improve self-efficacy.
The investigators will pilot test its effectiveness among a sample of Hispanic women who are at risk of obesity and diabetes by sending a culturally-sensitive and linguistically-appropriate text-based message three to 5 times a week, encouraging lifestyle modifications (diet and exercise education and behavior modification).
Detailed description
The investigators will collect data on 40 obese (Body Mass Index 30-45) Hispanic women ages 21 to 65 years. The purpose of this research study is to test the efficacy of a mobile phone text message-based intervention on weight loss.
After verifying eligibility and enrolling in the study, participants will come to Washington University School of Medicine, at Barnes-Jewish Hospital and fill out some questionnaires. The investigators will perform a brief exam that measures the lean and fat tissue using Dual Energy x-ray Absorptiometry (DXA) technology and will also do a modified 3-hour oral glucose tolerance test (MOGTT).
Participants will wear an accelerometer (activity monitor) over a 7-day period at the beginning (before being randomized and enrolled in the intervention) and at the end of the study.
Half of the participants will be randomized to the intervention group. The intervention group will be enrolled in the CareMessage™ Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss. The control group will receive an initial talk about weight loss but will not be enrolled in any program or intervention.
After six months have passed, participants will return to Washington University School of Medicine, regardless of the group they were assigned to, for two final visits (a short one, to pick up another activity monitor seven days before the study ends, and a longer visit, to do some final testing and fill out some questionnaires).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: CareMessage™The intervention group will be enrolled in the CareMessage™ Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss. |
| Control Group | Other | Behavioral: Control ConditionThe control group will receive the control condition. They will hear an initial talk about weight loss but will not be enrolled in any program or intervention. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Participants with a history of and/or current mental or physical disabilities.
- Participants with BMI over 45
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 |
|---|---|---|
| CareMessage™Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss. | Behavioural | Intervention Group |
| Control ConditionControl condition will receive an initial talk about weight loss but will not be enrolled in any program or intervention. | Behavioural | Control Group |
Primary outcome
Body mass Index
Time frame: 6 months
is a measure of body fat based on height and weight that applies to adult men and women.
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 15 Feb 2019.
- 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.
Diana Parra principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareMessage™ in people with Obesity, run by Washington University School of Medicine 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 0 inclusion and 2 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 15 Feb 2019. 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?
Body mass Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2019.