ObesityNCT01241578
Improving Behavioral Weight Loss Via Electronic Handheld Device
A study testing Lifestyle Counseling in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Standard behavioral treatment (SBT) for obesity is often effective, but weight losses are highly variable, and patients sometimes fail to achieve a "successful" weight loss of 5-10% of their starting weight. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jun 2012
- 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
- Body Mass Index (kg/m2) of 30-45.
- English language fluency
- Basic familiarity with cell phone technology
- Ability to read at a 6th grade level
- Availability to attend weekly treatment sessions in Providence, RI
Who cannot join
- Any heart condition that limits ability to participate in physical activity
- Chest Pain
- Any cognitive of physical limitation that would preclude use of a smartphone
- Serious mental illness
- Historical or current eating disorder
- Previous or planned bariatric surgery
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- Use of weight loss medication
- Recent pregnancy or a plan to become pregnant in the next 6 months
- Participation in a study at the Weight Control and Diabetes Research Center within the last two years
- A weight loss of greater than 5% body weight in the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Resarch Center
Providence, Rhode Island, 02903
About this study
Standard behavioral treatment (SBT) for obesity is often effective, but weight losses are highly variable, and patients sometimes fail to achieve a "successful" weight loss of 5-10% of their starting weight. It has been suggested that the "one size fits all" approach of SBT may be responsible for many treatment failures because the intervention is not sufficiently tailored to address the unique needs of each patient. Moreover, treatment is delivered in the clinic, not in the settings and the times when it is needed most. The primary aim of the proposed research is to develop and pilot test a behavioral weight loss intervention that combines in-person sessions with treatment delivered via an electronic handheld device to provide highly individualized weight loss treatment in patients' natural environment. In a critical departure from previous research using cell phone technology, the portion of intervention that is delivered via handheld device will be of equal sophistication and importance to the portion of the intervention that is delivered in face-to-face treatment sessions. The proposed study seeks to determine the feasibility and preliminary efficacy of an individually tailored behavioral weight loss program that integrates clinic-based care and smartphone technology.
- Conditions
- Obesity
- Being tested
- Lifestyle Counseling
- Keywords
- Obesity, Behavior Therapy, Lifestyle, Technology, Cellular Phone
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CounselingBehavioural
Participants receive instructions for making healthy changes to their diet and physical activity habits.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Phone Intervention | Experimental | Participants receive a behavioral intervention via mobile phone and brief in-person counseling sessions. Receives: Behavioral: Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Participants' body weight measured in kg.
Measured: Baseline and weekly for 24-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2012
- Study completionJun 2012
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Obesity Society
- Responsible party
- Principal investigator, John Graham Thomas, The Miriam Hospital
- Investigators
- Graham Thomas, Ph.D., Principal investigator, Brown UniversityRena R Wing, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241578
- Sponsor's protocol ID
- TOSNewInvestigator2009
- Status last verified
- Apr 2015
- First submitted
- 12 Nov 2010
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Behavioral Weight Loss Via Electronic Handheld Device
- ClinicalTrials.gov ID
- NCT01241578
- Acronym / sponsor ID
- TOSNewInvestigator2009
- Conditions
- Obesity
- Keywords
- Obesity, Behavior Therapy, Lifestyle, Technology, Cellular Phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- The Obesity Society
- Study start
- Feb 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Nov 2010 (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.
Standard behavioral treatment (SBT) for obesity is often effective, but weight losses are highly variable, and patients sometimes fail to achieve a "successful" weight loss of 5-10% of their starting weight. It has been suggested that the "one size fits all" approach of SBT may be responsible for many treatment failures because the intervention is not sufficiently tailored to address the unique needs of each patient. Moreover, treatment is delivered in the clinic, not in the settings and the times when it is needed most. The primary aim of the proposed research is to develop and pilot test a behavioral weight loss intervention that combines in-person sessions with treatment delivered via an electronic handheld device to provide highly individualized weight loss treatment in patients' natural environment. In a critical departure from previous research using cell phone technology, the portion of intervention that is delivered via handheld device will be of equal sophistication and importance to the portion of the intervention that is delivered in face-to-face treatment sessions. The proposed study seeks to determine the feasibility and preliminary efficacy of an individually tailored behavioral weight loss program that integrates clinic-based care and smartphone technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Phone Intervention | Experimental | Behavioral: Lifestyle CounselingParticipants receive a behavioral intervention via mobile phone and brief in-person counseling sessions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body Mass Index (kg/m2) of 30-45.
- English language fluency
- Basic familiarity with cell phone technology
- Ability to read at a 6th grade level
- Availability to attend weekly treatment sessions in Providence, RI
Key exclusion criteria (10 listed)
- Any heart condition that limits ability to participate in physical activity
- Chest Pain
- Any cognitive of physical limitation that would preclude use of a smartphone
- Serious mental illness
- Historical or current eating disorder
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 |
|---|---|---|
| Lifestyle CounselingParticipants receive instructions for making healthy changes to their diet and physical activity habits. | Behavioural | Mobile Phone Intervention |
Primary outcome
Weight
Time frame: Baseline and weekly for 24-weeks.
Participants' body weight measured in kg.
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 Apr 2015.
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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.
Graham Thomas, Ph.D. principal investigator
Brown University
Rena R Wing, Ph.D. principal investigator
Brown 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 Lifestyle Counseling in people with 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 5 inclusion and 10 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 Apr 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: Baseline and weekly for 24-weeks.). 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 Apr 2015.