Overweight and ObesityNCT04055259
A Mobile Health and Wellness Coaching Intervention for Weight Loss
A study testing mobile Health and Wellness Coaching in people with Overweight and Obesity and Health Behavior, run by Edward Via Virginia College of Osteopathic Medicine at 1 site in United States.
Trial summary
The objective of this study was to assess the effectiveness of a 6-month text-based mobile health and wellness (mHWC) intervention, as compared to usual care (UC), for weight loss in adults. Participants were randomly assigned to one of the two groups (mHWC or UC). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Health Behavior
- What is being tested?
- mobile Health and Wellness Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 6 Dec 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥27 kg/m^2
- Waist circumference ≥35 inches (women) or ≥40 inches (men)
- Own an Android smartphone or iPhone capable of running the Nudge and Fitbit applications.
- Indicate sending at least one text-based (e.g., SMS, Facebook, Twitter) message via their smartphone on most days
Who cannot join
- Pregnant
- Pacemaker or other electronic implant
- Weight ≥400 pounds
- Weight loss ≥5% of bodyweight in previous 6 months
- High cardiovascular risk, as determined by Physical Activity Readiness Questionnaire (PAR-Q) and physician review, as needed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Auburn University Pharmaceutical Care Center
Auburn, Alabama, 36849
About this study
Official title: Six-Month Randomized Controlled Trial of Text-Based Mobile Health and Wellness Coaching for Weight Loss
The objective of this study was to assess the effectiveness of a 6-month text-based mobile health and wellness (mHWC) intervention, as compared to usual care (UC), for weight loss in adults. Participants were randomly assigned to one of the two groups (mHWC or UC). At the beginning of the study, both groups were given a Fitbit wearable device, and a weight scale. All participants also received a counseling session from a dietician focused on diet, physical activity, and sleep, and were set up on the Nudge app, a commercially-available mHWC platform. Participants in the mHWC group received text-based coaching messages via Nudge and did not return to the clinic for the duration of the 6-month intervention. Those in the UC group met once a month with a pharmacist or dietician for 6 months. In both groups, the focus was on facilitating health behavior change related to diet, physical activity, and sleep to promote weight loss.
We hypothesized that weight loss at 6 months would be greater in the mHWC group vs. the UC group.
- Conditions
- Overweight and Obesity, Health Behavior
- Being tested
- mobile Health and Wellness Coaching, Usual Care
- Keywords
- Health and Wellness Coaching
- Medical subject headings
- Overweight, Obesity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile Health and Wellness CoachingBehavioural
Participants in the mobile health and wellness coaching (mHWC) group received text-based mHWC messages and did not return to the clinic until the end of the 6 month intervention. Messages were sent at least weekly and focused on facilitating the adoption and maintenance of health behaviors related to diet, physical activity and sleep to promote weight loss. Participants could respond via text at any time. The Nudge platform was used for all messaging.
Usual CareBehavioural
Participants in the usual care (UC) group met in-person once a month with either a pharmacist or dietician for the duration of the 6-month intervention. The focus of these sessions was on facilitating the adoption and maintenance of health behaviors related to diet, physical activity and sleep to promote weight loss. These participants were set up on the Nudge app, but they did not use the mHWC (texting) feature.
| Study group | Role | What they receive |
|---|---|---|
| mobile Health and Wellness Coaching | Experimental | Not described Receives: Behavioral: mobile Health and Wellness Coaching |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Assessed at baseline and follow-up
Measured: 6 months (mean 193 ± 21 days)
Secondary outcomes (4)
Change Waist Circumference
Assessed at baseline and follow-up
Measured: 6 months (mean 193 ± 21 days)
Change in Self-Reported Physical Activity
Assessed via Exercise Vital Sign (EVS) at baseline and follow-up. The EVS is used to assess via self-report the amount of physical activity or exercise an individual engages in during an average week. It asks: 1. On average, how many days a week do you perform physical activity or exercise, such as walking or jogging? and 2. On average, how many minutes of physical activity or exercise do you perform on those days?
Measured: 6 months (mean 193 ± 21 days)
Change in Self-Reported Sleep Quantity
Assessed via Pittsburgh Sleep Quality Index (PSQI) at baseline and follow-up. The PSQI is used to assess via self-report an individual's nightly average sleep quality and quantity over the previous 30 day period. As for quality, the higher the score, the lower the quality of sleep.
Measured: 6 months (mean 193 ± 21 days)
Change in Self-Reported Daily Caloric Consumption
Assessed via the Automated Self-Assessment 24-hour (ASA24) Dietary Assessment at baseline and follow-up. The ASA24 is a detailed 24-hour food recall that can be used to estimate via self-report diet quality and quantity.
Measured: 6 months (mean 193 ± 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start14 Aug 2017
- Primary completion7 May 2018
- Study completion6 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Via Virginia College of Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Auburn University
- Responsible party
- Sponsor
- Investigators
- Joshua C Hollingsworth, PharmD, PhD, Principal investigator, VCOM-Auburn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055259
- Sponsor's protocol ID
- 17-278 MR 1707
- Status last verified
- Nov 2019
- First submitted
- 7 Aug 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six-Month Randomized Controlled Trial of Text-Based Mobile Health and Wellness Coaching for Weight Loss
- ClinicalTrials.gov ID
- NCT04055259
- Acronym / sponsor ID
- 17-278 MR 1707
- Conditions
- Overweight and Obesity, Health Behavior
- Keywords
- Health and Wellness Coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Edward Via Virginia College of Osteopathic MedicineUniversity, hospital or other
- Collaborators
- Auburn University
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 6 Dec 2018 (actual)
- First posted
- 13 Aug 2019 (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.
The objective of this study was to assess the effectiveness of a 6-month text-based mobile health and wellness (mHWC) intervention, as compared to usual care (UC), for weight loss in adults. Participants were randomly assigned to one of the two groups (mHWC or UC). At the beginning of the study, both groups were given a Fitbit wearable device, and a weight scale. All participants also received a counseling session from a dietician focused on diet, physical activity, and sleep, and were set up on the Nudge app, a commercially-available mHWC platform. Participants in the mHWC group received text-based coaching messages via Nudge and did not return to the clinic for the duration of the 6-month intervention. Those in the UC group met once a month with a pharmacist or dietician for 6 months. In both groups, the focus was on facilitating health behavior change related to diet, physical activity, and sleep to promote weight loss.
We hypothesized that weight loss at 6 months would be greater in the mHWC group vs. the UC group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobile Health and Wellness Coaching | Experimental | Behavioral: mobile Health and Wellness Coaching |
| Usual Care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≥27 kg/m^2
- Waist circumference ≥35 inches (women) or ≥40 inches (men)
- Own an Android smartphone or iPhone capable of running the Nudge and Fitbit applications.
- Indicate sending at least one text-based (e.g., SMS, Facebook, Twitter) message via their smartphone on most days
Key exclusion criteria (5 listed)
- Pregnant
- Pacemaker or other electronic implant
- Weight ≥400 pounds
- Weight loss ≥5% of bodyweight in previous 6 months
- High cardiovascular risk, as determined by Physical Activity Readiness Questionnaire (PAR-Q) and physician review, as needed.
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 |
|---|---|---|
| mobile Health and Wellness CoachingParticipants in the mobile health and wellness coaching (mHWC) group received text-based mHWC messages and did not return to the clinic until the end of the 6 month intervention. Messages were sent at least weekly and focused on facilitating the adoption and maintenance of health behaviors related to diet, physical activity and sleep to promote weight loss. Participants could respond via text at any time. The Nudge platform was used for all messaging. | Behavioural | mobile Health and Wellness Coaching |
| Usual CareParticipants in the usual care (UC) group met in-person once a month with either a pharmacist or dietician for the duration of the 6-month intervention. The focus of these sessions was on facilitating the adoption and maintenance of health behaviors related to diet, physical activity and sleep to promote weight loss. These participants were set up on the Nudge app, but they did not use the mHWC (texting) feature. | Behavioural | Usual Care |
Primary outcome
Change in Weight
Time frame: 6 months (mean 193 ± 21 days)
Assessed at baseline and follow-up
4 secondary outcomes
Change Waist Circumference
Time frame: 6 months (mean 193 ± 21 days)
Change in Self-Reported Physical Activity
Time frame: 6 months (mean 193 ± 21 days)
Change in Self-Reported Sleep Quantity
Time frame: 6 months (mean 193 ± 21 days)
Change in Self-Reported Daily Caloric Consumption
Time frame: 6 months (mean 193 ± 21 days)
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 7 Nov 2019.
- Individual participant dataSharing planned: No. There are currently no plans to share IPD with other researchers.
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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.
Joshua C Hollingsworth, PharmD, PhD principal investigator
VCOM-Auburn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile Health and Wellness Coaching in people with Overweight and Obesity and Health Behavior, run by Edward Via Virginia College of Osteopathic 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 4 inclusion and 5 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 7 Nov 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?
Change in Weight (time frame: 6 months (mean 193 ± 21 days)). 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 7 Nov 2019.