ObesityNCT04378322
Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People
A study testing Nutrition and food purchasing tool + telenutrition, Nutrition and food purchasing tool and Nutrition education tool in people with Obesity, run by Zipongo.
Trial summary
The purpose of this research study is to determine the effectiveness of nutrition tools to support weight loss among obese individuals. All participation will be based online and there will be no in-person visits. Participants will be given nutrition support tools for 6 months. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Nutrition and food purchasing tool + telenutrition, Nutrition and food purchasing tool and Nutrition education tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2020to Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 30 kg/m2 Male or female 18 or older Non-institutionalized Able and willing to provide informed consent Willing to change diet for 3 months Has access to a scale to weigh themselves Lives in NY state
Who cannot join
- Refuse or are unable to provide informed consent to participate in the study Undergoing active cancer treatment Has type 1 or 2 diabetes Stage 3+ CKD or kidney failure Are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months Report of congestive heart failure Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa) Current or former Zipongo users
About this study
The purpose of this research study is to determine the effectiveness of nutrition tools to support weight loss among obese individuals. All participation will be based online and there will be no in-person visits. Participants will be given nutrition support tools for 6 months. Participants will be asked to report their weight and diet at the start of the study, and every month for 6 months during the study period. Participants will additionally be asked to report weight and diet at 12 months, 18 months, and 24 months after the start of the study. Total study duration will be 2 years.
Read the detailed description
Obesity is a major public health burden. Weight loss among obese participants may improve future health outcomes and financial burden to the healthcare system and employers.
The effect of personalized meal planning and online food purchasing and delivery on weight loss and management is unknown.
Design: This trial is an online, three-arm randomized trial to compare a meal planning and telenutrition tool, a meal planning tool only, and MyPlate optimization.
Participants will be assigned to randomly assigned in a 1:1:1 ratio to one of the three groups.
Participants will follow the intervention for 6 months after randomization and will be followed for an additional 1.5 years after randomization.
Participants will report dietary behavior and weight at baseline and each month of the intervention (6 months), 12 months, 18 months, and 24 months.
Population Approximately 300 participants will be enrolled and randomized (100 per arm). Participants will be adults living in New York state who are obese (at least a BMI of 30 kg/m2).
Outcomes Primary outcome: weight change after 6 months Other outcomes: waist circumference; blood pressure, dietary changes, cooking, meal planning, and eating out frequencies
- Conditions
- Obesity
- Being tested
- Nutrition and food purchasing tool + telenutrition, Nutrition and food purchasing tool, Nutrition education tool
- Keywords
- weight loss, digital, nutrition, healthy eating, food purchasing, meal planning, obese, online, MyPlate
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and food purchasing tool + telenutritionBehavioural
Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks) and schedule appointments with a registered dietitian.
Nutrition and food purchasing toolBehavioural
Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).
Nutrition education toolBehavioural
Participants will be asked to review nutrition education materials online.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and food purchasing tool + telenutrition | Active comparator | Participants will use an online nutrition and food purchasing tool in addition to telenutrition. Receives: Behavioral: Nutrition and food purchasing tool + telenutrition |
| Nutrition and food purchasing tool | Active comparator | Participants will use an online nutrition and food purchasing tool. Receives: Behavioral: Nutrition and food purchasing tool |
| Nutrition education tool | Active comparator | Participants will be exposed to an online nutrition education materials. Receives: Behavioral: Nutrition education tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Weight will be measured using a scale and self-reported.
Measured: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Secondary outcomes (3)
Waist circumference
Waist circumference will be measured using a tape measure and self-reported.
Measured: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Blood pressure
Blood pressure will be a self-reported assessment at a clinic or pharmacy.
Measured: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Change in diet quality
Diet quality will be assessed using a food frequency questionnaire.
Measured: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start4 May 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJul 2022 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zipongo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378322
- Sponsor's protocol ID
- 102
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 7 May 2020
- 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 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Weight Loss Study: Nutrition Support Tools and Weight Loss Among Obese People
- ClinicalTrials.gov ID
- NCT04378322
- Acronym / sponsor ID
- 102
- Conditions
- Obesity
- Keywords
- weight loss, digital, nutrition, healthy eating, food purchasing, meal planning, obese, online
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ZipongoIndustry (pharma, biotech, devices)
- Study start
- 4 May 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 7 May 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.
The purpose of this research study is to determine the effectiveness of nutrition tools to support weight loss among obese individuals. All participation will be based online and there will be no in-person visits. Participants will be given nutrition support tools for 6 months. Participants will be asked to report their weight and diet at the start of the study, and every month for 6 months during the study period. Participants will additionally be asked to report weight and diet at 12 months, 18 months, and 24 months after the start of the study. Total study duration will be 2 years.
Detailed description
Obesity is a major public health burden. Weight loss among obese participants may improve future health outcomes and financial burden to the healthcare system and employers.
The effect of personalized meal planning and online food purchasing and delivery on weight loss and management is unknown.
Design: This trial is an online, three-arm randomized trial to compare a meal planning and telenutrition tool, a meal planning tool only, and MyPlate optimization.
Participants will be assigned to randomly assigned in a 1:1:1 ratio to one of the three groups.
Participants will follow the intervention for 6 months after randomization and will be followed for an additional 1.5 years after randomization.
Participants will report dietary behavior and weight at baseline and each month of the intervention (6 months), 12 months, 18 months, and 24 months.
Population Approximately 300 participants will be enrolled and randomized (100 per arm). Participants will be adults living in New York state who are obese (at least a BMI of 30 kg/m2).
Outcomes Primary outcome: weight change after 6 months Other outcomes: waist circumference; blood pressure, dietary changes, cooking, meal planning, and eating out frequencies
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutrition and food purchasing tool + telenutrition | Active comparator | Behavioral: Nutrition and food purchasing tool + telenutritionParticipants will use an online nutrition and food purchasing tool in addition to telenutrition. |
| Nutrition and food purchasing tool | Active comparator | Behavioral: Nutrition and food purchasing toolParticipants will use an online nutrition and food purchasing tool. |
| Nutrition education tool | Active comparator | Behavioral: Nutrition education toolParticipants will be exposed to an online nutrition education materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≥ 30 kg/m2 Male or female 18 or older Non-institutionalized Able and willing to provide informed consent Willing to change diet for 3 months Has access to a scale to weigh themselves Lives in NY state
Key exclusion criteria (1 listed)
- Refuse or are unable to provide informed consent to participate in the study Undergoing active cancer treatment Has type 1 or 2 diabetes Stage 3+ CKD or kidney failure Are pregnant or breastfeeding, have given birth in the last three months, or are planning to be pregnant in the next 3 months Report of congestive heart failure Diagnosed with an eating disorder (e.g. anorexia nervosa or bulimia nervosa) Current or former Zipongo users
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 and food purchasing tool + telenutritionParticipants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks) and schedule appointments with a registered dietitian. | Behavioural | Nutrition and food purchasing tool + telenutrition |
| Nutrition and food purchasing toolParticipants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks). | Behavioural | Nutrition and food purchasing tool |
| Nutrition education toolParticipants will be asked to review nutrition education materials online. | Behavioural | Nutrition education tool |
Primary outcome
Weight change
Time frame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Weight will be measured using a scale and self-reported.
3 secondary outcomes
Waist circumference
Time frame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Blood pressure
Time frame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Change in diet quality
Time frame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and food purchasing tool + telenutrition, Nutrition and food purchasing tool and Nutrition education tool in people with Obesity, run by Zipongo.
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: status not confirmed, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Weight change (time frame: Baseline and end of months 1, 2, 3, 4, 5, 6, 12, 18, and 24). 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 May 2020.