ObesityNCT01095458
Phone Versus Clinical Approach to Weight Loss
A study testing Phone versus Clinic Weight Management Programs in people with Obesity, run by University of Kansas at 1 site in United States.
Trial summary
Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment generally involves a behavioral weight loss clinic that emphasizes nutrition, physical activity, and lifestyle changes and is delivered face-to-face between health educators and small groups… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Phone versus Clinic Weight Management Programs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years,
- BMI between 25 and 39.9,
- Clearance from PCP.
Who cannot join
- Research project within previous 6 months,
- Exercise > 500 kcal/week,
- Pregnancy,
- Serious medical risk,
- Eating disorders,
- Use of special diets.
Trial locations and contacts
1 site in 1 country.
United States1 site
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, 66045
About this study
Official title: Equivalent Weight Loss for Phone and Clinic Weight Management Programs
Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment generally involves a behavioral weight loss clinic that emphasizes nutrition, physical activity, and lifestyle changes and is delivered face-to-face between health educators and small groups of participants. This delivery system is time consuming, expensive, and presents numerous barriers to the participant. We have developed a phone based delivery system that eliminates many of these barriers by substituting group conference calls for clinics and by delivering weight loss materials and products directly to the participant.
Hypothesis 1: We expect equivalent weight loss from baseline for phone and clinic groups and have defined equivalence as no greater than 4 kg difference between groups based on our pilot data and potential for clinical significance.
Read more
Hypothesis 2: During weight maintenance it is likely that participants will experience some weight re-gain. We expect both phone and clinic groups to re-gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights.
Hypothesis 3: We will complete a cost analysis to determine which delivery method is more economical. Specifically, we expect the phone delivery system to be more cost effective than that of the in-person clinics.
Read the detailed description
Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment is delivered face-to-face between care providers and small groups of participants and this is time consuming, expensive, and presents numerous barriers to the participant such as travel, conflict with work and home, need for child care, loss of anonymity, and others as well as the care provider such as office space, meeting rooms, inventory, etc. A pilot study of a phone based delivery system versus a traditional clinic has been completed with no difference in weight loss. The phone approach may eliminate many of the barriers of a traditional clinic by substituting conference calls for clinics and by delivering weight loss materials and products directly to the participant. In this fashion, the care provider and participants can reside in any location and receive the same information by conference phone call as that provided by clinic, and receive educational materials, weight management products, etc. by air or ground transportation.
This proposed investigation is a randomized, equivalency trial to test the effectiveness of a phone based weight management program compared to a traditional face-to-face clinic program for weight loss and weight maintenance. It is expected that at 6 months participants in the phone and clinic groups will show equivalent weight loss and that weight loss will be at least 10% lower than baseline. During weight maintenance some weight gain may occur. However, we expect both phone and clinic groups to gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights.
A formal cost analysis will be used to determine differences between phone and clinic approaches and extensive process analysis will be used to collect both qualitative and quantitative data to assess how well the programs were implemented as originally designed, challenges and barriers to effective implementation, initial and continual use of program specified activities, quality assurance measures, etc.
Relevance: If successful, the phone approach may eliminate many of the barriers inherent to the traditional face-to-face clinic, may be less expensive, and would potentially open weight management to any individual with access to a phone. We believe the likelihood of translation of this research to the public sector would seem reasonable and promising.
- Conditions
- Obesity
- Being tested
- Phone versus Clinic Weight Management Programs
- Keywords
- Obesity, Phone vs Clinical methods
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone versus Clinic Weight Management ProgramsBehavioural
Also called Phone based weight management, Clinic based weight management
To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
| Study group | Role | What they receive |
|---|---|---|
| Phone based weight management group | Experimental | Group based weight management program delivered via conference calls Receives: Behavioral: Phone versus Clinic Weight Management Programs |
| Clinic based weight management group | Experimental | Traditional clinical based group weight management program Receives: Behavioral: Phone versus Clinic Weight Management Programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalent weight loss for phone and clinic groups.
Measured: 6 months
Secondary outcomes (2)
Equal weight management/regain.
Measured: 12 months
Cost Analysis
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startJul 2007
- Primary completionJul 2011
- Study completionJun 2013
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Donnelly, University of Kansas
- Investigators
- Joseph E Donnelly, EdD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095458
- Sponsor's protocol ID
- HSCL16529
- Other IDs
- R01DK076063
- Status last verified
- Apr 2014
- First submitted
- 26 Mar 2010
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Donnelly JE, Goetz J, Gibson C, Sullivan DK, Lee R, Smith BK, Lambourne K, Mayo MS, Hunt S, Lee JH, Honas JJ, Washburn RA. Equivalent weight loss for weight management programs delivered by phone and clinic. Obesity (Silver Spring). 2013 Oct;21(10):1951-9. doi: 10.1002/oby.20334. Epub 2013 May 25.
PubMed 23408579Lambourne K, Washburn RA, Gibson C, Sullivan DK, Goetz J, Lee R, Smith BK, Mayo MS, Donnelly JE. Weight management by phone conference call: a comparison with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial. Contemp Clin Trials. 2012 Sep;33(5):1044-55. doi: 10.1016/j.cct.2012.05.014. Epub 2012 Jun 1.
PubMed 22664647
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equivalent Weight Loss for Phone and Clinic Weight Management Programs
- ClinicalTrials.gov ID
- NCT01095458
- Acronym / sponsor ID
- HSCL16529
- Conditions
- Obesity
- Keywords
- Obesity, Phone vs Clinical methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Mar 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.
Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment generally involves a behavioral weight loss clinic that emphasizes nutrition, physical activity, and lifestyle changes and is delivered face-to-face between health educators and small groups of participants. This delivery system is time consuming, expensive, and presents numerous barriers to the participant. We have developed a phone based delivery system that eliminates many of these barriers by substituting group conference calls for clinics and by delivering weight loss materials and products directly to the participant.
Hypothesis 1: We expect equivalent weight loss from baseline for phone and clinic groups and have defined equivalence as no greater than 4 kg difference between groups based on our pilot data and potential for clinical significance.
Hypothesis 2: During weight maintenance it is likely that participants will experience some weight re-gain. We expect both phone and clinic groups to re-gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights.
Hypothesis 3: We will complete a cost analysis to determine which delivery method is more economical. Specifically, we expect the phone delivery system to be more cost effective than that of the in-person clinics.
Detailed description
Weight loss and maintenance continues to be problematic for individuals who are overweight or obese. State-of-the-art treatment is delivered face-to-face between care providers and small groups of participants and this is time consuming, expensive, and presents numerous barriers to the participant such as travel, conflict with work and home, need for child care, loss of anonymity, and others as well as the care provider such as office space, meeting rooms, inventory, etc. A pilot study of a phone based delivery system versus a traditional clinic has been completed with no difference in weight loss. The phone approach may eliminate many of the barriers of a traditional clinic by substituting conference calls for clinics and by delivering weight loss materials and products directly to the participant. In this fashion, the care provider and participants can reside in any location and receive the same information by conference phone call as that provided by clinic, and receive educational materials, weight management products, etc. by air or ground transportation.
This proposed investigation is a randomized, equivalency trial to test the effectiveness of a phone based weight management program compared to a traditional face-to-face clinic program for weight loss and weight maintenance. It is expected that at 6 months participants in the phone and clinic groups will show equivalent weight loss and that weight loss will be at least 10% lower than baseline. During weight maintenance some weight gain may occur. However, we expect both phone and clinic groups to gain a similar amount of weight and that weight for both groups at 18 months will be significantly less than baseline weights.
A formal cost analysis will be used to determine differences between phone and clinic approaches and extensive process analysis will be used to collect both qualitative and quantitative data to assess how well the programs were implemented as originally designed, challenges and barriers to effective implementation, initial and continual use of program specified activities, quality assurance measures, etc.
Relevance: If successful, the phone approach may eliminate many of the barriers inherent to the traditional face-to-face clinic, may be less expensive, and would potentially open weight management to any individual with access to a phone. We believe the likelihood of translation of this research to the public sector would seem reasonable and promising.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone based weight management group | Experimental | Behavioral: Phone versus Clinic Weight Management ProgramsGroup based weight management program delivered via conference calls |
| Clinic based weight management group | Experimental | Behavioral: Phone versus Clinic Weight Management ProgramsTraditional clinical based group weight management program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years,
- BMI between 25 and 39.9,
- Clearance from PCP.
Key exclusion criteria (6 listed)
- Research project within previous 6 months,
- Exercise > 500 kcal/week,
- Pregnancy,
- Serious medical risk,
- Eating disorders,
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 |
|---|---|---|
| Phone versus Clinic Weight Management ProgramsAlso: Phone based weight management, Clinic based weight managementTo determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone. | Behavioural | Clinic based weight management group, Phone based weight management group |
Primary outcome
Equivalent weight loss for phone and clinic groups.
Time frame: 6 months
2 secondary outcomes
Equal weight management/regain.
Time frame: 12 months
Cost Analysis
Time frame: 18 months
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 4 Apr 2014.
- Results publication: PubMed 23408579Donnelly JE, Goetz J, Gibson C, Sullivan DK, Lee R, Smith BK, Lambourne K, Mayo MS, Hunt S, Lee JH, Honas JJ, Washburn RA. Equivalent weight loss for weight management programs delivered by phone and clinic. Obesity (Silver Spring). 2013 Oct;21(10):1951-9. doi: 10.1002/oby.20334. Epub 2013 May 25.
- Derived from this study: PubMed 22664647Lambourne K, Washburn RA, Gibson C, Sullivan DK, Goetz J, Lee R, Smith BK, Mayo MS, Donnelly JE. Weight management by phone conference call: a comparison with a traditional face-to-face clinic. Rationale and design for a randomized equivalence trial. Contemp Clin Trials. 2012 Sep;33(5):1044-55. doi: 10.1016/j.cct.2012.05.014. Epub 2012 Jun 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.
Joseph E Donnelly, EdD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone versus Clinic Weight Management Programs in people with Obesity, run by University of Kansas 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 6 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 4 Apr 2014. 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?
Equivalent weight loss for phone and clinic groups. (time frame: 6 months). 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 NCT01095458, 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 4 Apr 2014.