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Web-based Weight Loss Intervention

Primary Purpose

Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lower carbohydrate diet

Higher fiber diet

Physical activity focused

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring nutrition, diet, genetics, physical activity, weight loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

23andMe
23andMe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Randomized- Lower carbohydrate diet

Randomized- Higher fiber diet

Randomized- Exercise focused

Participant chooses- Lower carbohydrate diet

Participant chooses- Higher fiber diet

Participant chooses- Exercise focused

Arm Description

Outcomes

Primary Outcome Measures

Change in weight from week 1 to week 12 of intervention

Secondary Outcome Measures

Change in waist circumference from week 1 to week 12 of intervention

Change in waist-to-hip ratio from week 1 to week 12 of intervention

Full Information

NCT ID

NCT03400696

First Posted

January 4, 2018

Last Updated

June 2, 2020

Sponsor

23andMe, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03400696

Brief Title

Web-based Weight Loss Intervention

Official Title

Web-based Weight Loss Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

December 27, 2017 (Actual)

Primary Completion Date

January 8, 2019 (Actual)

Study Completion Date

April 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

23andMe, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity

Keywords

nutrition, diet, genetics, physical activity, weight loss

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Participants are randomized to either a RCT or 'Participant choice' block, with 3 parallel interventions within each block

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

63656 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Randomized- Lower carbohydrate diet

Arm Type

Experimental

Arm Title

Randomized- Higher fiber diet

Arm Type

Experimental

Arm Title

Randomized- Exercise focused

Arm Type

Experimental

Arm Title

Participant chooses- Lower carbohydrate diet

Arm Type

Experimental

Arm Title

Participant chooses- Higher fiber diet

Arm Type

Experimental

Arm Title

Participant chooses- Exercise focused

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Lower carbohydrate diet

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Higher fiber diet

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Physical activity focused

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in weight from week 1 to week 12 of intervention

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in waist circumference from week 1 to week 12 of intervention

Time Frame

12 weeks

Title

Change in waist-to-hip ratio from week 1 to week 12 of intervention

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Geoffrey Benton, PhD

Organizational Affiliation

23andMe, Inc.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Liana Del Gobbo, PhD

Organizational Affiliation

23andMe, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

23andMe

City

Mountain View

State/Province

California

ZIP/Postal Code

94041

Country

United States

Facility Name

23andMe

City

Mountain View

State/Province

California

ZIP/Postal Code

94043

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26253612

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.

Results Reference

background

PubMed Identifier

26692578

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. Erratum In: Obesity (Silver Spring). 2016 Mar;24(3):757.

Results Reference

background

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Web-based Weight Loss Intervention

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