Web-based Weight Loss Intervention

Overweight and Obesity Clinical Trial

Official title:

Web-based Weight Loss Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400696
• Other study ID #: 23andMe_WLI001
• Status: Completed
• Phase: N/A
• Start date: December 27, 2017
• Est. completion date: April 16, 2019

Study information

• Verified date: June 2020
• Source: 23andMe, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63656
• Est. completion date: April 16, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Lower carbohydrate diet
Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity
• Higher fiber diet
Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity
• Physical activity focused
Focused on aerobic and resistance exercise, while following dietary guidelines <https://www.choosemyplate.gov>

Locations

Country	Name	City	State
United States	23andMe	Mountain View	California
United States	23andMe	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
23andMe, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. Erratum in: Obesity (Silver Spring). 2016 Mar;24(3):757. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight from week 1 to week 12 of intervention		12 weeks
Secondary	Change in waist circumference from week 1 to week 12 of intervention		12 weeks
Secondary	Change in waist-to-hip ratio from week 1 to week 12 of intervention		12 weeks