ObesityiDIPNCT04605640
Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 2
A study testing Weight Management Intervention in people with Obesity and Overweight, 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 70 years
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- Weight Management Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 10 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index in the overweight or obese range (BMI) >28 kg/m2 (if Asian, BMI >25kg/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; 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 two years; fluent in reading and writing English.
Who cannot join
- age <18 or >70 years; body mass index of <28 kg/m2 (if Asian, BMI <25kg/m2); currently pregnant; currently lactating; self-reported with severe metabolic, cardiovascular, or musculoskeletal disease; use insulin injection; 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 FFQ.
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 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
- Obesity, Overweight, Weight Loss, Diet Habit
- Being tested
- Weight Management Intervention
- Medical subject headings
- Obesity, Overweight, Weight Loss, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Management InterventionBehavioural
Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Weight Management Intervention | Experimental | 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. Participants will be followed by daily self-weighing for 1 year after intervention. Receives: Behavioral: Weight Management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight in kilograms measured on a standard scale (Withings, US)
Measured: Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month
Secondary outcomes (8)
Waist circumference
Waist circumference in centimeters measured using a standard measuring tape
Measured: Change from baseline (0 month) to 6 month, 12 month, 24 month
Hip circumference
Hip circumference in centimeters measured using a standard measuring tape
Measured: Change from baseline (0 month) to 6 month, 12 month, 24 month
Body composition
Body fat measured using InBody 270
Measured: Change from baseline (0 month) to 6 month, 12 month, 24 month
Body composition
muscle mass measured using InBody 270
Measured: Change from baseline (0 month) to 6 month, 12 month, 24 month
Protein intake
Protein intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)
Measured: Change from baseline (0 month) to 12 month
Protein intake
Protein intake in grams and grams/100 kilo-calories using a 24-hour dietary record
Measured: Periodically from baseline (0 month) to 12 month
Fiber intake
Fiber intake in grams and grams/100 kilo-calories using a food frequency questionnaire (FFQ)
Measured: Change from baseline (0 month) to 12 month
Fiber intake
Fiber intake in grams and grams/100 kilo-calories using a 24-hour dietary record
Measured: Periodically from baseline (0 month) to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start26 Mar 2019
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
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
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605640
- Sponsor's protocol ID
- 18069_cohort2
- Acronym
- iDIP
- Status last verified
- Jul 2021
- First submitted
- 26 Oct 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Diet Improvement Program for Weight Loss and Maintenance
- ClinicalTrials.gov ID
- NCT04605640
- Acronym / sponsor ID
- iDIP / 18069_cohort2
- Conditions
- Obesity, Overweight, Weight Loss, Diet Habit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 28 Oct 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
| Arm | Type | Receives |
|---|---|---|
| Weight Management Intervention | Experimental | Behavioral: Weight Management InterventionDuring 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. Participants will be followed by daily self-weighing for 1 year after intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- body mass index in the overweight or obese range (BMI) >28 kg/m2 (if Asian, BMI >25kg/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; 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 two years; fluent in reading and writing English.
Key exclusion criteria (1 listed)
- age <18 or >70 years; body mass index of <28 kg/m2 (if Asian, BMI <25kg/m2); currently pregnant; currently lactating; self-reported with severe metabolic, cardiovascular, or musculoskeletal disease; use insulin injection; 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 FFQ.
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 Management InterventionParticipants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires. | Behavioural | Weight Management Intervention |
Primary outcome
Body weight
Time frame: Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month
Body weight in kilograms measured on a standard scale (Withings, US)
8 secondary outcomes
Waist circumference
Time frame: Change from baseline (0 month) to 6 month, 12 month, 24 month
Hip circumference
Time frame: Change from baseline (0 month) to 6 month, 12 month, 24 month
Body composition
Time frame: Change from baseline (0 month) to 6 month, 12 month, 24 month
Body composition
Time frame: Change from baseline (0 month) to 6 month, 12 month, 24 month
Protein intake
Time frame: Change from baseline (0 month) to 12 month
Protein intake
Time frame: Periodically from baseline (0 month) to 12 month
Fiber intake
Time frame: Change from baseline (0 month) to 12 month
Fiber intake
Time frame: Periodically from baseline (0 month) to 12 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 23 Jul 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intervention in people with Obesity and Overweight, 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 1 inclusion and 1 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 Jul 2021. 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?
Body weight (time frame: Change from baseline (0 month) to 6 month, 12 month, 18 month, and 24 month). 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 23 Jul 2021.