ObesityRICENCT01203995
Remote Information Counseling for Elders
A study testing Nutrition information and Nutrition education and exercise training in people with Obesity, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to provide testing methods of delivering nutrition and physical activity services for weight loss. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Nutrition information and Nutrition education and exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 40 to 64 years.
- One or more CHC visits in the past 12 months.
- Body-mass index of ≥30 and <50.
- English speaking.
- Access to telephone.
- A permanent address.
- Willingness to be randomized.
- Willingness to have computer installed in home.
Who cannot join
- Any serious medical condition likely to hinder accurate weight measurement, or for which weight loss is contraindicated or could cause weight loss (e.g., cancer).
- Current diagnosis of psychosis or bipolar disorder.
- Unstable or recent onset of cardiovascular disease within 6 months or presence of congestive heart failure
- Illness that might be associated with weight change, such as asthma (because of treatment with corticosteroids), psychosis
- Use of medications that might cause weight gain such as hypoglycemic oral medicines or insulin, anti-depressants, and weight loss medications.
- Unwilling or unable to provide informed consent.
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- Receiving disability insurance.
- Pregnant or nursing in past 6 months, or plans to become pregnant within 12 months.
- Enrolled in a weight loss program or study or member of household enrolled in study.
- Residence outside of Marion County, Indiana.
- Residence relocation plans within 12 months.
- Planned or prior bariatric surgery.
- Substance abuse.
- History of treatment for eating disorder.
- Unstable weight with loss or gain of ≥ 5% in last 3 months.
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to provide testing methods of delivering nutrition and physical activity services for weight loss.
- Conditions
- Obesity
- Being tested
- Nutrition information, Nutrition education and exercise training
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition informationBehavioural
Brief nutrition education with take home reference materials and portion size tools
Nutrition education and exercise trainingBehavioural
Twice per week nutrition education and exercise class held either in-clinic or through vide-conference.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| brief nutrition education | Experimental | Not described Receives: Behavioral: Nutrition information |
| In Center training | Active comparator | Not described Receives: Behavioral: Nutrition education and exercise training |
| Video Conference training | Experimental | Not described Receives: Behavioral: Nutrition education and exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Measured: two months
Secondary outcomes (2)
2-Minute Step Test
Number of steps completed in two minutes
Measured: two months
Chair stand test
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012
- Study completionOct 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.
- More trials run by Indiana 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Hemmerlein, Indiana University
- Investigators
- Daniel O Clark, PhD., Principal investigator, Indiana University Center for Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203995
- Sponsor's protocol ID
- 0710-65B
- Acronym
- RICE
- Status last verified
- Mar 2013
- First submitted
- 1 Sep 2010
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Information Counseling for Elders
- ClinicalTrials.gov ID
- NCT01203995
- Acronym / sponsor ID
- RICE / 0710-65B
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Sep 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.
The purpose of this study is to provide testing methods of delivering nutrition and physical activity services for weight loss.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | – |
| brief nutrition education | Experimental | Behavioral: Nutrition information |
| In Center training | Active comparator | Behavioral: Nutrition education and exercise training |
| Video Conference training | Experimental | Behavioral: Nutrition education and exercise training |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 40 to 64 years.
- One or more CHC visits in the past 12 months.
- Body-mass index of ≥30 and <50.
- English speaking.
- Access to telephone.
Key exclusion criteria (16 listed)
- Any serious medical condition likely to hinder accurate weight measurement, or for which weight loss is contraindicated or could cause weight loss (e.g., cancer).
- Current diagnosis of psychosis or bipolar disorder.
- Unstable or recent onset of cardiovascular disease within 6 months or presence of congestive heart failure
- Illness that might be associated with weight change, such as asthma (because of treatment with corticosteroids), psychosis
- Use of medications that might cause weight gain such as hypoglycemic oral medicines or insulin, anti-depressants, and weight loss medications.
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 |
|---|---|---|
| Nutrition informationBrief nutrition education with take home reference materials and portion size tools | Behavioural | brief nutrition education |
| Nutrition education and exercise trainingTwice per week nutrition education and exercise class held either in-clinic or through vide-conference. | Behavioural | In Center training, Video Conference training |
Primary outcome
BMI
Time frame: two months
2 secondary outcomes
2-Minute Step Test
Time frame: two months
Chair stand test
Time frame: 2 month
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 2 Apr 2013.
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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.
Daniel O Clark, PhD. principal investigator
Indiana University Center for Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition information and Nutrition education and exercise training in people with Obesity, run by Indiana 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 8 inclusion and 16 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 2 Apr 2013. 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?
BMI (time frame: two months). 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 2 Apr 2013.