Web-based Weight Loss Intervention

NCT ID: NCT03400696

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-27
• Study Completion Date: 2019-04-16

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Randomized- Lower carbohydrate diet

Group Type: EXPERIMENTAL

Lower carbohydrate diet

Intervention Type: BEHAVIORAL

Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity

Randomized- Higher fiber diet

Group Type: EXPERIMENTAL

Higher fiber diet

Intervention Type: BEHAVIORAL

Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity

Randomized- Exercise focused

Group Type: EXPERIMENTAL

Physical activity focused

Intervention Type: BEHAVIORAL

Focused on aerobic and resistance exercise, while following dietary guidelines \<https://www.choosemyplate.gov\>

Participant chooses- Lower carbohydrate diet

Group Type: EXPERIMENTAL

Lower carbohydrate diet

Intervention Type: BEHAVIORAL

Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity

Participant chooses- Higher fiber diet

Group Type: EXPERIMENTAL

Higher fiber diet

Intervention Type: BEHAVIORAL

Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity

Participant chooses- Exercise focused

Group Type: EXPERIMENTAL

Physical activity focused

Intervention Type: BEHAVIORAL

Focused on aerobic and resistance exercise, while following dietary guidelines \<https://www.choosemyplate.gov\>

Interventions

Lower carbohydrate diet

Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity

Intervention Type: BEHAVIORAL

Higher fiber diet

Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity

Intervention Type: BEHAVIORAL

Physical activity focused

Focused on aerobic and resistance exercise, while following dietary guidelines \<https://www.choosemyplate.gov\>

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

23andMe, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey Benton, PhD

Role: PRINCIPAL_INVESTIGATOR

23andMe, Inc.

Liana Del Gobbo, PhD

Role: STUDY_DIRECTOR

23andMe, Inc.

Locations

23andMe

Mountain View, California, United States

23andMe

Mountain View, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26253612 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26692578 (View on PubMed)

Other Identifiers

23andMe_WLI001

Identifier Type: -

Identifier Source: org_study_id