Weight LossNCT02279017
mHealth Messages to Sustain Recent Weight Loss - Phase 2
A study testing mHealth Texting for Weight Loss in people with Weight Loss, run by Duke University at 1 site in United States.
Trial summary
To assess the feasibility to translate an automated weight loss message intervention to a weight loss clinic population. Aim 1: To assess feasibility of translating the intervention in a clinic for patients who recently completed a structured weight loss program. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- mHealth Texting for Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jan 2017
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A client of Duke diet and Fitness Center (DFC)
- Are able to speak and read English
- Should complete a diet and fitness program at the DFC.
- Client should own a mobile smart phone to personally receive text messages.
- Client should have access to a web-based survey to self-report their weight.
Who cannot join
- No exclusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center, Diet and Fitness Center
Durham, North Carolina, 27710
About this study
Official title: Mobile Health Messages to Sustain Recent Weight Loss - Phase 2
To assess the feasibility to translate an automated weight loss message intervention to a weight loss clinic population.
Aim 1: To assess feasibility of translating the intervention in a clinic for patients who recently completed a structured weight loss program.
Aim 2: To assess the ability to capture a trajectory of self-reported weight over 6 months through an automated intervention.
Read the detailed description
The investigators will recruit 100 participants who are clients at the Duke Diet and Fitness Center. At baseline the investigators will collect demographic information such as, their age, weight, education. When participants complete their respective program at the DFC they will receive a daily weight loss sustaining text message at 8:00 A.M. for 60 days. Participants will also receive weekly messages for 6 months asking them to self-report their weight. Thereafter, they will receive an automated message monthly for 18 months asking them to self-report their weight.
- Conditions
- Weight Loss
- Being tested
- mHealth Texting for Weight Loss
- Keywords
- Mobile Technology, Diet and Fitness
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Texting for Weight LossBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss | Other | We will send the study participate a daily text message for 2 months to their phone at 8 A.M. and a weekly text message for 6 months asking them to report their weight through a 2-question online survey. After that, a monthly text message for 18 months asking them to report their weight. Receives: Behavioral: mHealth Texting for Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's weight loss
The study is being done to asses the ability to translate an automated weight loss message intervention to a weight loss clinic population.
Measured: 2 years
Percentage of subjects who self-report weight to the clinic
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Shaw, RN, Phd, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279017
- Sponsor's protocol ID
- Pro00057562
- Status last verified
- Mar 2016
- First submitted
- 28 Oct 2014
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Messages to Sustain Recent Weight Loss - Phase 2
- ClinicalTrials.gov ID
- NCT02279017
- Acronym / sponsor ID
- Pro00057562
- Conditions
- Weight Loss
- Keywords
- Mobile Technology, Diet and Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Oct 2014 (estimated)
- 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.
To assess the feasibility to translate an automated weight loss message intervention to a weight loss clinic population.
Aim 1: To assess feasibility of translating the intervention in a clinic for patients who recently completed a structured weight loss program.
Aim 2: To assess the ability to capture a trajectory of self-reported weight over 6 months through an automated intervention.
Detailed description
The investigators will recruit 100 participants who are clients at the Duke Diet and Fitness Center. At baseline the investigators will collect demographic information such as, their age, weight, education. When participants complete their respective program at the DFC they will receive a daily weight loss sustaining text message at 8:00 A.M. for 60 days. Participants will also receive weekly messages for 6 months asking them to self-report their weight. Thereafter, they will receive an automated message monthly for 18 months asking them to self-report their weight.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weight Loss | Other | Behavioral: mHealth Texting for Weight LossWe will send the study participate a daily text message for 2 months to their phone at 8 A.M. and a weekly text message for 6 months asking them to report their weight through a 2-question online survey. After that, a monthly text message for 18 months asking them to report their weight. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A client of Duke diet and Fitness Center (DFC)
- Are able to speak and read English
- Should complete a diet and fitness program at the DFC.
- Client should own a mobile smart phone to personally receive text messages.
- Client should have access to a web-based survey to self-report their weight.
Key exclusion criteria (1 listed)
- No exclusions
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 |
|---|---|---|
| mHealth Texting for Weight Loss | Behavioural | Weight Loss |
Primary outcome
Subject's weight loss
Time frame: 2 years
The study is being done to asses the ability to translate an automated weight loss message intervention to a weight loss clinic population.
Percentage of subjects who self-report weight to the clinic
Time frame: 2 years
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 26 Jan 2017.
Related trials for Weight Loss
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
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.
Ryan Shaw, RN, Phd principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Texting for Weight Loss in people with Weight Loss, run by Duke University 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 1 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 26 Jan 2017. 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?
Subject's weight loss (time frame: 2 years). The study lists 2 primary outcomes in all. 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 26 Jan 2017.