Evaluation of Body Composition Improvement With Visceral Adiposity-Focused Anti-Obesity Telehealth Program

NCT ID: NCT05219240

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Cardiovascular Diseases Metabolic Syndrome Metabolic Disease

Keywords

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visceral adiposity BMI body composition obesity cardiovascular disease metabolic syndrome metabolic disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Program participants

20Lighter Program

Intervention Type OTHER

Visceral Adiposity-Focused Anti-Obesity Telehealth Program

Interventions

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20Lighter Program

Visceral Adiposity-Focused Anti-Obesity Telehealth Program

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women 18 years of age and older, who enroll in the weight loss program are eligible for inclusion of the data review.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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20Lighter

INDUSTRY

Sponsor Role lead

Responsible Party

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Jessica W. Barnes, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Barnes, PhD

Role: PRINCIPAL_INVESTIGATOR

20Lighter

Locations

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20Lighter Telehealth Program

Little Rock, Arkansas, United States

Site Status RECRUITING

20Lighter Telehealth Program

Cheyenne, Wyoming, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Barnes, PhD

Role: CONTACT

Phone: 307-287-1555

Email: [email protected]

Facility Contacts

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Jessica Barnes, PhD

Role: primary

Jessica Barnes, PhD

Role: primary

References

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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.

Reference Type 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.

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PMID: 9813653 (View on PubMed)

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.

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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.

Reference Type BACKGROUND
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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.

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Reference Type BACKGROUND
PMID: 23569168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27411588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27282289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23497604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25251676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26135345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25540982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22889512 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 25404320 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25857868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24215592 (View on PubMed)

Other Identifiers

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20L02

Identifier Type: -

Identifier Source: org_study_id