Weight LossNCT04353726
Knowledge-based Dietary Weight Management.
A study testing Weight management in people with Weight Loss and Dietary Modifications, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
This research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Weight Loss, Dietary Modifications, Obesity
- What is being tested?
- Weight management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to Apr 2021
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-64 years;
- body mass index (BMI) >28 kg/m2;
- not currently pregnant or lactating;
- have Wi-Fi at home, a working email, and an iPhone or Android smartphone.
- no self-reported severe metabolic, cardiovascular or musculoskeletal disease;
- not using insulin injection;
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- able to attend the 22 (1 hour) diet improvement sessions.
- willing to lose 20 lb. or more for 6 months and maintain a healthy weight for one year.
- keep weighing their weight for one and a half years.
- fluent in reading and writing English.
Who cannot join
- age <18 or >64 years;
- body mass index of <28 kg/m2;
- currently pregnant;
- currently lactating;
- self-reported with the severe metabolic, cardiovascular or musculoskeletal disease;
- use insulin injection;
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- not able to attend the 22 (1 hour) diet improvement sessions for 1 year;
- failed to set up a Wi-Fi scale;
- failed to submit a food frequency questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Individualized Diet Improvement Program (iDip) for Weight Loss and Maintenance.
This research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.
- Conditions
- Weight Loss, Dietary Modifications, Obesity, Sustainability
- Being tested
- Weight management
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight managementOther
During a 12-month period, participants will attend a total of 22 diet improvement sessions, each of which will last approximately 1 hour. Twelve sessions will be held in the first 5 months and will be focused on safe and efficient weight loss. The participants will learn to create a personalized weight loss diet from their kitchen based on their diet practice and food preference. The next 10 sessions will be held in the last 7 months and will be focused on weight maintenance and healthy eating. The participants will build skills to select foods and create meals that prevent them from overeating.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Eligible participants will be in an intervention group led by a registered dietitian Receives: Other: Weight management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight in kilograms
Measured: Change from baseline body weight at 6 months
Body weight
Body weight in kilograms
Measured: Change from baseline body weight at 12 months
Body weight
Body weight in kilograms
Measured: Change from baseline body weight at 18 months
Secondary outcomes (6)
Waist circumference
Waist circumference in centimeters
Measured: Change from baseline waist circumference at 12 months
Hip circumference
Hip circumference in centimeters
Measured: Change from baseline hip circumference at 12 months
Protein intake
Protein intake in grams and caloric intake will be combined to report density in g/100kcal
Measured: Change from baseline protein intake at 6 months
Protein intake
Protein intake in grams and caloric intake will be combined to report density in g/100kcal
Measured: Change from baseline protein intake at 12 months
Fiber intake
Fiber intake in grams and caloric intake will be combined to report density in g/100kcal
Measured: Change from baseline fiber intake at 6 months
Fiber intake
Fiber intake in grams and caloric intake will be combined to report density in g/100kcal
Measured: Change from baseline fiber intake at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start5 Sep 2017
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Model description
- Before and after study design
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mindy Lee, University of Illinois at Urbana-Champaign
- Investigators
- Nakamura T Manabu, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353726
- Sponsor's protocol ID
- 18069
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Diet Improvement Program (iDip) for Weight Loss and Maintenance.
- ClinicalTrials.gov ID
- NCT04353726
- Acronym / sponsor ID
- 18069
- Conditions
- Weight Loss, Dietary Modifications, Obesity, Sustainability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 20 Apr 2020 (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.
This research is to develop a weight loss and weight maintenance program through dietary modifications for adults with obesity. Although scientific studies have shown the feasibility of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious dietary weight management program is widely available, and thus bariatric surgery remains the most reliable approach for weight loss/management. Safe and effective dietary weight loss and subsequent weight maintenance require flexible, individualized advice by an experienced dietitian/nutritionist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after study design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Weight managementEligible participants will be in an intervention group led by a registered dietitian |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- age 18-64 years;
- body mass index (BMI) >28 kg/m2;
- not currently pregnant or lactating;
- have Wi-Fi at home, a working email, and an iPhone or Android smartphone.
- no self-reported severe metabolic, cardiovascular or musculoskeletal disease;
Key exclusion criteria (9 listed)
- age <18 or >64 years;
- body mass index of <28 kg/m2;
- currently pregnant;
- currently lactating;
- self-reported with the severe metabolic, cardiovascular or musculoskeletal disease;
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 |
|---|---|---|
| Weight managementDuring a 12-month period, participants will attend a total of 22 diet improvement sessions, each of which will last approximately 1 hour. Twelve sessions will be held in the first 5 months and will be focused on safe and efficient weight loss. The participants will learn to create a personalized weight loss diet from their kitchen based on their diet practice and food preference. The next 10 sessions will be held in the last 7 months and will be focused on weight maintenance and healthy eating. The participants will build skills to select foods and create meals that prevent them from overeating. | Other | Intervention group |
Primary outcome
Body weight
Time frame: Change from baseline body weight at 6 months
Body weight in kilograms
Body weight
Time frame: Change from baseline body weight at 12 months
Body weight in kilograms
Body weight
Time frame: Change from baseline body weight at 18 months
Body weight in kilograms
6 secondary outcomes
Waist circumference
Time frame: Change from baseline waist circumference at 12 months
Hip circumference
Time frame: Change from baseline hip circumference at 12 months
Protein intake
Time frame: Change from baseline protein intake at 6 months
Protein intake
Time frame: Change from baseline protein intake at 12 months
Fiber intake
Time frame: Change from baseline fiber intake at 6 months
Fiber intake
Time frame: Change from baseline fiber intake at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication will be shared.
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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.
Nakamura T Manabu, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight management in people with Weight Loss and Dietary Modifications, run by University of Illinois at Urbana-Champaign 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Apr 2020. 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?
Results are not available in the source record.
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?
Body weight (time frame: Change from baseline body weight at 6 months). The study lists 3 primary outcomes in all. 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 20 Apr 2020.