NCT05219240

Brief Summary

A retrospective review of body composition changes in patients who participate in a 9-week non-invasive intensive health care provider supervised weight loss program as an overall cohort and in sub-cohorts of interest.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

5 years

First QC Date

January 21, 2022

Last Update Submit

December 18, 2022

Conditions

ObesityCardiovascular DiseasesMetabolic SyndromeMetabolic Disease

Keywords

visceral adiposityBMIbody compositionobesitycardiovascular diseasemetabolic syndromemetabolic disease

Outcome Measures

Primary Outcomes (6)

  • Bodyweight Change

    Change in bodyweight

    Baseline to 90 days

  • Body Mass Index (BMI) Change

    Change in Body Mass Index (BMI)

    Baseline to 90 days

  • Visceral Adiposity Change

    Change in Visceral Adiposity

    Baseline to 90 days

  • Body Fat % Change

    Change in Body Fat %

    Baseline to 90 days

  • Lean Body Mass Change

    Change in Lean Body Mass

    Baseline to 90 days

  • Intracellular Fluid % Change

    Change in Intracellular Fluid %

    Baseline to 90 days

Study Arms (1)

Program participants

Other: 20Lighter Program

Interventions

20Lighter ProgramOTHER

Visceral Adiposity-Focused Anti-Obesity Telehealth Program

Program participants

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

20Lighter program participants

You may not qualify if:

  • Pregnancy or breastfeeding
  • Current treatment of cancer
  • Major organ transplant with immunosuppressant medication,
  • Adult with a strict vegetarian diet,
  • Certain psychiatric conditions (schizophrenia, bipolar disorder, manic depression)
  • Adults with a BMI \< 25.0 and no cardiovascular or metabolic comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

20Lighter Telehealth Program

Little Rock, Arkansas, 72205, United States

RECRUITING

20Lighter Telehealth Program

Cheyenne, Wyoming, 82007, United States

RECRUITING

Related Publications (19)

  • Fryar CD, Carroll MD, Afful J. Prevalence of overweight, obesity, and severe obesity among children and adolescents aged 2-19 years: United States, 1963-1965 through 2017-2018. NCHS Health E-Stats. 2020.

    BACKGROUND

  • Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults--The Evidence Report. National Institutes of Health. Obes Res. 1998 Sep;6 Suppl 2:51S-209S. No abstract available.

    PMID: 9813653BACKGROUND

  • Anderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr. 2001 Nov;74(5):579-84. doi: 10.1093/ajcn/74.5.579.

    PMID: 11684524BACKGROUND

  • Balasubramanian P, Longo VD. Growth factors, aging and age-related diseases. Growth Horm IGF Res. 2016 Jun;28:66-8. doi: 10.1016/j.ghir.2016.01.001. Epub 2016 Jan 7.

    PMID: 26883276BACKGROUND

  • Barnosky AR, Hoddy KK, Unterman TG, Varady KA. Intermittent fasting vs daily calorie restriction for type 2 diabetes prevention: a review of human findings. Transl Res. 2014 Oct;164(4):302-11. doi: 10.1016/j.trsl.2014.05.013. Epub 2014 Jun 12.

    PMID: 24993615BACKGROUND

  • Bhutani S, Klempel MC, Kroeger CM, Trepanowski JF, Varady KA. Alternate day fasting and endurance exercise combine to reduce body weight and favorably alter plasma lipids in obese humans. Obesity (Silver Spring). 2013 Jul;21(7):1370-9. doi: 10.1002/oby.20353. Epub 2013 May 29.

    PMID: 23408502BACKGROUND

  • Choi IY, Piccio L, Childress P, Bollman B, Ghosh A, Brandhorst S, Suarez J, Michalsen A, Cross AH, Morgan TE, Wei M, Paul F, Bock M, Longo VD. A Diet Mimicking Fasting Promotes Regeneration and Reduces Autoimmunity and Multiple Sclerosis Symptoms. Cell Rep. 2016 Jun 7;15(10):2136-2146. doi: 10.1016/j.celrep.2016.05.009. Epub 2016 May 26.

    PMID: 27239035BACKGROUND

  • Collier R. Intermittent fasting: the science of going without. CMAJ. 2013 Jun 11;185(9):E363-4. doi: 10.1503/cmaj.109-4451. Epub 2013 Apr 8. No abstract available.

    PMID: 23569168BACKGROUND

  • Di Biase S, Lee C, Brandhorst S, Manes B, Buono R, Cheng CW, Cacciottolo M, Martin-Montalvo A, de Cabo R, Wei M, Morgan TE, Longo VD. Fasting-Mimicking Diet Reduces HO-1 to Promote T Cell-Mediated Tumor Cytotoxicity. Cancer Cell. 2016 Jul 11;30(1):136-146. doi: 10.1016/j.ccell.2016.06.005.

    PMID: 27411588BACKGROUND

  • Dorff TB, Groshen S, Garcia A, Shah M, Tsao-Wei D, Pham H, Cheng CW, Brandhorst S, Cohen P, Wei M, Longo V, Quinn DI. Safety and feasibility of fasting in combination with platinum-based chemotherapy. BMC Cancer. 2016 Jun 10;16:360. doi: 10.1186/s12885-016-2370-6.

    PMID: 27282289BACKGROUND

  • Eshghinia S, Mohammadzadeh F. The effects of modified alternate-day fasting diet on weight loss and CAD risk factors in overweight and obese women. J Diabetes Metab Disord. 2013 Jan 9;12(1):4. doi: 10.1186/2251-6581-12-4.

    PMID: 23497604BACKGROUND

  • Hoddy KK, Kroeger CM, Trepanowski JF, Barnosky A, Bhutani S, Varady KA. Meal timing during alternate day fasting: Impact on body weight and cardiovascular disease risk in obese adults. Obesity (Silver Spring). 2014 Dec;22(12):2524-31. doi: 10.1002/oby.20909. Epub 2014 Sep 24.

    PMID: 25251676BACKGROUND

  • Horne BD, Muhlestein JB, Anderson JL. Health effects of intermittent fasting: hormesis or harm? A systematic review. Am J Clin Nutr. 2015 Aug;102(2):464-70. doi: 10.3945/ajcn.115.109553. Epub 2015 Jul 1.

    PMID: 26135345BACKGROUND

  • Johnstone A. Fasting for weight loss: an effective strategy or latest dieting trend? Int J Obes (Lond). 2015 May;39(5):727-33. doi: 10.1038/ijo.2014.214. Epub 2014 Dec 26.

    PMID: 25540982BACKGROUND

  • Klempel MC, Kroeger CM, Varady KA. Alternate day fasting (ADF) with a high-fat diet produces similar weight loss and cardio-protection as ADF with a low-fat diet. Metabolism. 2013 Jan;62(1):137-43. doi: 10.1016/j.metabol.2012.07.002. Epub 2012 Aug 11.

    PMID: 22889512BACKGROUND

  • Longo VD, Panda S. Fasting, Circadian Rhythms, and Time-Restricted Feeding in Healthy Lifespan. Cell Metab. 2016 Jun 14;23(6):1048-1059. doi: 10.1016/j.cmet.2016.06.001.

    PMID: 27304506BACKGROUND

  • Mattson MP, Allison DB, Fontana L, Harvie M, Longo VD, Malaisse WJ, Mosley M, Notterpek L, Ravussin E, Scheer FA, Seyfried TN, Varady KA, Panda S. Meal frequency and timing in health and disease. Proc Natl Acad Sci U S A. 2014 Nov 25;111(47):16647-53. doi: 10.1073/pnas.1413965111. Epub 2014 Nov 17.

    PMID: 25404320BACKGROUND

  • Patterson RE, Laughlin GA, LaCroix AZ, Hartman SJ, Natarajan L, Senger CM, Martinez ME, Villasenor A, Sears DD, Marinac CR, Gallo LC. Intermittent Fasting and Human Metabolic Health. J Acad Nutr Diet. 2015 Aug;115(8):1203-12. doi: 10.1016/j.jand.2015.02.018. Epub 2015 Apr 6. No abstract available.

    PMID: 25857868BACKGROUND

  • Varady KA, Bhutani S, Klempel MC, Kroeger CM, Trepanowski JF, Haus JM, Hoddy KK, Calvo Y. Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. Nutr J. 2013 Nov 12;12(1):146. doi: 10.1186/1475-2891-12-146.

    PMID: 24215592BACKGROUND

MeSH Terms

Conditions

ObesityCardiovascular DiseasesMetabolic SyndromeMetabolic Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Jessica Barnes, PhD

    20Lighter

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Barnes, PhD

CONTACT

307-287-1555staff@20Lighter.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2022

First Posted

February 2, 2022

Study Start

January 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

US(2)