Taking Action to Thrive - A Healthy Lifestyle Intervention Pilot Study

NCT03478345 | Completed

• 1 other identifier: 111739
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

There have been some preliminary studies, primarily in animals, that suggest that exposure to some of the chemicals in our everyday environment, such as the chemicals found in plastics, may cause weight gain. It is not clear whether this also happens in humans, or whether decreasing exposure to these chemicals can improve success with weight loss when people adopt healthy lifestyle changes. The THRIVE Study is a 4-week group healthy lifestyle education program that is designed to determine whether:

• changes in dietary habits and the types of personal care products used can decrease a person's exposure to chemicals in our environment that have been suggested to cause weight gain
• whether any measurable changes in body composition (fat tissue vs. lean tissue) can be seen as a result of participating in the healthy lifestyle program.

Conditions

Overweight, Obesity and Other Hyperalimentation

Outcome Measures

Primary Outcomes (2)

• Changes in urinary endocrine disrupting chemical levels (especially phthalates)

  Difference between urinary endocrine disrupting chemical levels from urine collected at the baseline study visit and urine collected at the final study visit.

  Six weeks

• Changes in body composition (weight and visceral adipose tissue volume)

  Difference between body weight and visceral adipose tissue volume (measured by dual x-ray absorptiometry) from baseline to final study visit.

  Six weeks

Secondary Outcomes (1)

• Correlation between dietary patterns and urinary endocrine disrupting chemical levels

  baseline

Study Arms (1)

THRIVE Study

EXPERIMENTAL

Behavioral: endocrine disruptor chemical reduction intervention

Interventions

endocrine disruptor chemical reduction intervention BEHAVIORAL

Participants will take part in a 4-week intervention consisting of a modified (shortened) version of the Diabetes Prevention Program diet and physical activity group education program, with instructions to reduce endocrine disruptor chemical exposure through changes in food handling and personal care products.

THRIVE Study

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Because of potential hormonal influences on body composition, eligibility criteria for this study requires being biologically female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female
• BMI \>25 kg/m2
• willingness to participate in the 4-week long study
• English speaking
• capable of giving informed consent.

You may not qualify if:

• males
• current smoker, or having quit smoking within the past 6 months
• currently or recently (past 6 months) pregnant or lactating, or planning to become pregnant in the next year
• engaging in \>150 minutes exercise/week
• weight loss of ≥5 pounds over the past 6 months
• post-menopausal
• pre-existing chronic diseases
• use of medications known to alter body composition such as hormone replacements, oral contraceptives, and steroids
• homeless persons, or individuals who have active drug/alcohol dependence or abuse history
• Non-English speaking

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Milken Institute School of Public Health, George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim Robien, PhD, RD

  Department of Exercise and Nutrition Sciences, Milken Institute School of Public Health, George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: March 13, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)