Clinical trial NCT03400696: Web-based Weight Loss Intervention
Official title: Web-based Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: nutrition, diet, genetics, physical activity, weight loss
Lead sponsor: 23andMe, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 63656
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to either a RCT or 'Participant choice' block, with 3 parallel interventions within each block
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in weight from week 1 to week 12 of intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in waist circumference from week 1 to week 12 of intervention
timeFrame: 12 weeks
measure: Change in waist-to-hip ratio from week 1 to week 12 of intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: 23andMe
state: California
city: Mountain View
country: United States
facility: 23andMe
state: California
Study officials:
affiliation: 23andMe, Inc.
name: Geoffrey Benton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 23andMe, Inc.
name: Liana Del Gobbo, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bray 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.