OverweightNCT01999244
Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss
A study testing Self-monitoring skills, Technology and Interventionist Contact in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Despite continued research on effective interventions, obesity remains a major public health issue in the United States. Current treatments, including behavioral weight management programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited reach, reducing the ability of these… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Self-monitoring skills, Technology and Interventionist Contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70
- BMI between 27 and 40 kg/m2
- Access to a computer and WIFI in the home
Who cannot join
- Weight over 340 lbs
- Physical limitations that prevent walking 1/4 mile without stopping
- Currently participating in another weight loss program or taking weight loss medication
- Currently pregnant, lactating, less than 6-months post-partum, or plans to become pregnant during the 6-month study period
- Uncontrolled hypertension or diabetes
- History of coronary heart disease
Show all 11Show fewer
- Terminal Illness
- Plans to relocate during the 6-month study period
- Substance Abuse
- Severe psychiatric disorders
- Dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control & Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Despite continued research on effective interventions, obesity remains a major public health issue in the United States. Current treatments, including behavioral weight management programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited reach, reducing the ability of these treatments to address the population-wide scope of the obesity epidemic. Recent advances in technology that improve the ease of self-monitoring and provide targeted feedback offer promise to help larger groups of individuals to lose weight. Despite the commercial popularity of these products, however, little research has been conducted to evaluate their impact on excess body weight or to determine how they should ideally be implemented. Two key questions need to be addressed. First, is use of self-monitoring technology sufficient to produce weight loss, or must this technology be combined with interventionist contact? Second, how cost-effective is a technology-based intervention, with and without interventionist contact? The current study is small prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC) to a technology only condition (TECH) and a technology plus interventionist support condition (TECH+INT). All participants will all be given basic weight management information knowledge and randomized to one of three conditions. Participants in the self-guided self-monitoring condition (SC) will receive traditional paper self-monitoring logs, a standard body weight scale, and a pedometer and calorie book; participants in the technology-based condition (TECH) will receive an electronic activity monitor and WiFi-enabled body weight scale, and will track caloric intake via an associated website; and participants in the interventionist contact condition (TECH+INT) will receive the same technology as in the TECH condition, combined with weekly interventionist contact delivered via telephone. We will compare the impact of each condition on weight loss and investigate preliminary cost-effectiveness.
- Conditions
- Overweight, Obesity
- Being tested
- Self-monitoring skills, Technology, Interventionist Contact
- Keywords
- Overweight, Obesity, Weight Loss, Self-monitoring, Food Records, Self-weighing, Technology
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-monitoring skillsBehavioural
TechnologyBehavioural
Interventionist ContactBehavioural
| Study group | Role | What they receive |
|---|---|---|
| SC | Experimental | Self-guided self-monitoring condition. Participants will receive standard self-monitoring tools and information on weight regulation. Receives: Behavioral: Self-monitoring skills |
| TECH | Experimental | Technology condition. Participants will receive self-monitoring technology and information regarding weight regulation. Receives: Behavioral: Self-monitoring skills; Behavioral: Technology |
| TECH+INT | Experimental | Technology plus interventionist contact arm. Participants will receive self-monitoring technology, information regarding weight regulation, and interventionist contact via telephone. Receives: Behavioral: Self-monitoring skills; Behavioral: Technology; Behavioral: Interventionist Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn M Ross, PhD MPH, Principal investigator, The Miriam HospitalRena R Wing, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999244
- Sponsor's protocol ID
- 209313
- Other IDs
- F32DK100069-01
- Status last verified
- Sep 2015
- First submitted
- 25 Nov 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Chhabria K, Ross KM, Sacco SJ, Leahey TM. The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17967. doi: 10.2196/17967.
PubMed 32720911Ross KM, Wing RR. Impact of newer self-monitoring technology and brief phone-based intervention on weight loss: A randomized pilot study. Obesity (Silver Spring). 2016 Aug;24(8):1653-9. doi: 10.1002/oby.21536. Epub 2016 Jul 1.
PubMed 27367614
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Self-Monitoring Technology and Interventionist Contact on Weight Loss
- ClinicalTrials.gov ID
- NCT01999244
- Acronym / sponsor ID
- 209313
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Weight Loss, Self-monitoring, Food Records, Self-weighing, Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Dec 2013 (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.
Despite continued research on effective interventions, obesity remains a major public health issue in the United States. Current treatments, including behavioral weight management programs, weight loss surgery, and pharmacotherapy, tend to be high in cost and have limited reach, reducing the ability of these treatments to address the population-wide scope of the obesity epidemic. Recent advances in technology that improve the ease of self-monitoring and provide targeted feedback offer promise to help larger groups of individuals to lose weight. Despite the commercial popularity of these products, however, little research has been conducted to evaluate their impact on excess body weight or to determine how they should ideally be implemented. Two key questions need to be addressed. First, is use of self-monitoring technology sufficient to produce weight loss, or must this technology be combined with interventionist contact? Second, how cost-effective is a technology-based intervention, with and without interventionist contact? The current study is small prospective, randomized pilot study comparing a self-guided self-monitoring condition (SC) to a technology only condition (TECH) and a technology plus interventionist support condition (TECH+INT). All participants will all be given basic weight management information knowledge and randomized to one of three conditions. Participants in the self-guided self-monitoring condition (SC) will receive traditional paper self-monitoring logs, a standard body weight scale, and a pedometer and calorie book; participants in the technology-based condition (TECH) will receive an electronic activity monitor and WiFi-enabled body weight scale, and will track caloric intake via an associated website; and participants in the interventionist contact condition (TECH+INT) will receive the same technology as in the TECH condition, combined with weekly interventionist contact delivered via telephone. We will compare the impact of each condition on weight loss and investigate preliminary cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SC | Experimental | Behavioral: Self-monitoring skillsSelf-guided self-monitoring condition. Participants will receive standard self-monitoring tools and information on weight regulation. |
| TECH | Experimental | Behavioral: Self-monitoring skills, Behavioral: TechnologyTechnology condition. Participants will receive self-monitoring technology and information regarding weight regulation. |
| TECH+INT | Experimental | Behavioral: Self-monitoring skills, Behavioral: Technology, Behavioral: Interventionist ContactTechnology plus interventionist contact arm. Participants will receive self-monitoring technology, information regarding weight regulation, and interventionist contact via telephone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 70
- BMI between 27 and 40 kg/m2
- Access to a computer and WIFI in the home
Key exclusion criteria (11 listed)
- Weight over 340 lbs
- Physical limitations that prevent walking 1/4 mile without stopping
- Currently participating in another weight loss program or taking weight loss medication
- Currently pregnant, lactating, less than 6-months post-partum, or plans to become pregnant during the 6-month study period
- Uncontrolled hypertension or diabetes
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 |
|---|---|---|
| Self-monitoring skills | Behavioural | SC, TECH, TECH+INT |
| Technology | Behavioural | TECH, TECH+INT |
| Interventionist Contact | Behavioural | TECH+INT |
Primary outcome
Weight
Time frame: 6 months post randomization
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 23 Sep 2015.
- Derived from this study: PubMed 32720911Chhabria K, Ross KM, Sacco SJ, Leahey TM. The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study. J Med Internet Res. 2020 Jul 28;22(7):e17967. doi: 10.2196/17967.
- Derived from this study: PubMed 27367614Ross KM, Wing RR. Impact of newer self-monitoring technology and brief phone-based intervention on weight loss: A randomized pilot study. Obesity (Silver Spring). 2016 Aug;24(8):1653-9. doi: 10.1002/oby.21536. Epub 2016 Jul 1.
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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.
Kathryn M Ross, PhD MPH principal investigator
The Miriam Hospital
Rena R Wing, PhD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoring skills, Technology and Interventionist Contact in people with Overweight and Obesity, run by The Miriam 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 3 inclusion and 11 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 23 Sep 2015. 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?
Weight (time frame: 6 months post randomization). 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 NCT01999244, which also lists 2 linked publications.
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 23 Sep 2015.