Overweight and ObesityNCT03400696
Web-based Weight Loss Intervention
A study testing Lower carbohydrate diet, Higher fiber diet and Physical activity focused in people with Overweight and Obesity, run by 23andMe, Inc. at 2 sites in United States.
Trial summary
Excess weight is a major risk factor underlying leading causes of death globally, including cardiovascular disease, type 2 diabetes, and some cancers. Among participants assigned to the same lifestyle intervention arms in prior weight loss randomized controlled trials, large inter-individual differences in weight loss… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Lower carbohydrate diet, Higher fiber diet and Physical activity focused
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63,656 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Dec 2017to 16 Apr 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- US-based men and women in self-reported 'good' or better health
- Consented to participate in research
- BMI 25-40 kg/m2
- Not actively on a weight loss plan
- Willing and able to modify eating and physical activity patterns
- Not under a doctor's care for a serious medical condition
Who cannot join
- Are pregnant, lactating, within 6 months postpartum, or planning to become pregnant in the next 6 months
- Have diabetes (type 1 or 2) or are on hypoglycemic medications
- Had a heart attack or stroke within the past year
- Are unable or unwilling to follow a physical activity or diet intervention due to a medical condition or doctor's orders
- Have an eating disorder
- Have severe depression, anxiety, or other psychiatric conditions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
23andMe
Mountain View, California, 94041
23andMe
Mountain View, California, 94043
About this study
Excess weight is a major risk factor underlying leading causes of death globally, including cardiovascular disease, type 2 diabetes, and some cancers. Among participants assigned to the same lifestyle intervention arms in prior weight loss randomized controlled trials, large inter-individual differences in weight loss success have been observed, ranging from >50lbs of weight loss to >10lbs of weight gain. Both genetic and non-genetic factors underlying differential adherence and weight loss success are poorly understood.
Read the detailed description
23andMe aims to recruit 91,227 adults to participate in a web-based weight loss intervention. Primary aims include: a.) to confirm whether AG/GG individuals at MTIF3 rs1885988 lose more weight on lifestyle interventions; and b.) to test the performance of a randomized controlled trial vs. self-selection study design in terms of weight loss, drop-outs, and adherence. Secondary (exploratory) analyses will focus on discovery of genetic and non-genetic predictors of weight loss success overall, and examination of potential interactions by intervention type. Web-administered intervention content, videos, and forums will be surfaced to participants every two weeks, and self-reported surveys will be surfaced weekly for the active intervention duration.
- Conditions
- Overweight and Obesity
- Being tested
- Lower carbohydrate diet, Higher fiber diet, Physical activity focused
- Keywords
- nutrition, diet, genetics, physical activity, weight loss
- Medical subject headings
- Overweight, Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower carbohydrate dietBehavioural
Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity
Higher fiber dietBehavioural
Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity
Physical activity focusedBehavioural
Focused on aerobic and resistance exercise, while following dietary guidelines <https://www.choosemyplate.gov>
| Study group | Role | What they receive |
|---|---|---|
| Randomized- Lower carbohydrate diet | Experimental | Not described Receives: Behavioral: Lower carbohydrate diet |
| Randomized- Higher fiber diet | Experimental | Not described Receives: Behavioral: Higher fiber diet |
| Randomized- Exercise focused | Experimental | Not described Receives: Behavioral: Physical activity focused |
| Participant chooses- Lower carbohydrate diet | Experimental | Not described Receives: Behavioral: Lower carbohydrate diet |
| Participant chooses- Higher fiber diet | Experimental | Not described Receives: Behavioral: Higher fiber diet |
| Participant chooses- Exercise focused | Experimental | Not described Receives: Behavioral: Physical activity focused |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight from week 1 to week 12 of intervention
Measured: 12 weeks
Secondary outcomes (2)
Change in waist circumference from week 1 to week 12 of intervention
Measured: 12 weeks
Change in waist-to-hip ratio from week 1 to week 12 of intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start27 Dec 2017
- Primary completion8 Jan 2019
- Study completion16 Apr 2019
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 Overweight and 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to either a RCT or 'Participant choice' block, with 3 parallel interventions within each block
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63,656 participants (actual)
Sponsor and investigators
- Lead sponsor
- 23andMe, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoffrey Benton, PhD, Principal investigator, 23andMe, Inc.Liana Del Gobbo, PhD, Study director, 23andMe, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400696
- Sponsor's protocol ID
- 23andMe_WLI001
- Status last verified
- Jun 2020
- First submitted
- 4 Jan 2018
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Papandonatos GD, Pan Q, Pajewski NM, Delahanty LM, Peter I, Erar B, Ahmad S, Harden M, Chen L, Fontanillas P; GIANT Consortium; Wagenknecht LE, Kahn SE, Wing RR, Jablonski KA, Huggins GS, Knowler WC, Florez JC, McCaffery JM, Franks PW; Diabetes Prevention Program and the Look AHEAD Research Groups. Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials. Diabetes. 2015 Dec;64(12):4312-21. doi: 10.2337/db15-0441. Epub 2015 Aug 7.
PubMed 26253612Bray MS, Loos RJ, McCaffery JM, Ling C, Franks PW, Weinstock GM, Snyder MP, Vassy JL, Agurs-Collins T; Conference Working Group. NIH working group report-using genomic information to guide weight management: From universal to precision treatment. Obesity (Silver Spring). 2016 Jan;24(1):14-22. doi: 10.1002/oby.21381.
PubMed 26692578
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Weight Loss Intervention
- ClinicalTrials.gov ID
- NCT03400696
- Acronym / sponsor ID
- 23andMe_WLI001
- Conditions
- Overweight and Obesity
- Keywords
- nutrition, diet, genetics, physical activity, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63,656 participants (actual)
- Lead sponsor
- 23andMe, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 17 Jan 2018 (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.
Excess weight is a major risk factor underlying leading causes of death globally, including cardiovascular disease, type 2 diabetes, and some cancers. Among participants assigned to the same lifestyle intervention arms in prior weight loss randomized controlled trials, large inter-individual differences in weight loss success have been observed, ranging from >50lbs of weight loss to >10lbs of weight gain. Both genetic and non-genetic factors underlying differential adherence and weight loss success are poorly understood.
Detailed description
23andMe aims to recruit 91,227 adults to participate in a web-based weight loss intervention. Primary aims include: a.) to confirm whether AG/GG individuals at MTIF3 rs1885988 lose more weight on lifestyle interventions; and b.) to test the performance of a randomized controlled trial vs. self-selection study design in terms of weight loss, drop-outs, and adherence. Secondary (exploratory) analyses will focus on discovery of genetic and non-genetic predictors of weight loss success overall, and examination of potential interactions by intervention type. Web-administered intervention content, videos, and forums will be surfaced to participants every two weeks, and self-reported surveys will be surfaced weekly for the active intervention duration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Participants are randomized to either a RCT or 'Participant choice' block, with 3 parallel interventions within each block
| Arm | Type | Receives |
|---|---|---|
| Randomized- Lower carbohydrate diet | Experimental | Behavioral: Lower carbohydrate diet |
| Randomized- Higher fiber diet | Experimental | Behavioral: Higher fiber diet |
| Randomized- Exercise focused | Experimental | Behavioral: Physical activity focused |
| Participant chooses- Lower carbohydrate diet | Experimental | Behavioral: Lower carbohydrate diet |
| Participant chooses- Higher fiber diet | Experimental | Behavioral: Higher fiber diet |
| Participant chooses- Exercise focused | Experimental | Behavioral: Physical activity focused |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- US-based men and women in self-reported 'good' or better health
- Consented to participate in research
- BMI 25-40 kg/m2
- Not actively on a weight loss plan
- Willing and able to modify eating and physical activity patterns
Key exclusion criteria (6 listed)
- Are pregnant, lactating, within 6 months postpartum, or planning to become pregnant in the next 6 months
- Have diabetes (type 1 or 2) or are on hypoglycemic medications
- Had a heart attack or stroke within the past year
- Are unable or unwilling to follow a physical activity or diet intervention due to a medical condition or doctor's orders
- Have an eating disorder
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 |
|---|---|---|
| Lower carbohydrate dietFocused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity | Behavioural | Participant chooses- Lower carbohydrate diet, Randomized- Lower carbohydrate diet |
| Higher fiber dietFocused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity | Behavioural | Participant chooses- Higher fiber diet, Randomized- Higher fiber diet |
| Physical activity focusedFocused on aerobic and resistance exercise, while following dietary guidelines <https://www.choosemyplate.gov> | Behavioural | Participant chooses- Exercise focused, Randomized- Exercise focused |
Primary outcome
Change in weight from week 1 to week 12 of intervention
Time frame: 12 weeks
2 secondary outcomes
Change in waist circumference from week 1 to week 12 of intervention
Time frame: 12 weeks
Change in waist-to-hip ratio from week 1 to week 12 of intervention
Time frame: 12 weeks
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 Jun 2020.
- Background: PubMed 26253612Papandonatos GD, Pan Q, Pajewski NM, Delahanty LM, Peter I, Erar B, Ahmad S, Harden M, Chen L, Fontanillas P; GIANT Consortium; Wagenknecht LE, Kahn SE, Wing RR, Jablonski KA, Huggins GS, Knowler WC, Florez JC, McCaffery JM, Franks PW; Diabetes Prevention Program and the Look AHEAD Research Groups. Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials. Diabetes. 2015 Dec;64(12):4312-21. doi: 10.2337/db15-0441. Epub 2015 Aug 7.
- Background: PubMed 26692578Bray MS, Loos RJ, McCaffery JM, Ling C, Franks PW, Weinstock GM, Snyder MP, Vassy JL, Agurs-Collins T; Conference Working Group. NIH working group report-using genomic information to guide weight management: From universal to precision treatment. Obesity (Silver Spring). 2016 Jan;24(1):14-22. doi: 10.1002/oby.21381.
- 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.
Geoffrey Benton, PhD principal investigator
23andMe, Inc.
Liana Del Gobbo, PhD study director
23andMe, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower carbohydrate diet, Higher fiber diet and Physical activity focused in people with Overweight and Obesity, run by 23andMe, Inc. at 2 sites 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 6 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in weight from week 1 to week 12 of intervention (time frame: 12 weeks). 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 NCT03400696, 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 Jun 2020.