NCT05622149

Brief Summary

The purpose of this study is to determine whether strength training can be used as a viable exercise modality for the purpose of inducing fat loss.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

March 19, 2018

Last Update Submit

November 17, 2022

Conditions

Keywords

resistance training; metabolism

Outcome Measures

Primary Outcomes (4)

  • Change in Fat Free Mass

    Fat Free Mass as measured from DXA and recorded in Kg

    0 and 16 weeks

  • Change in Fat Mass

    Fat Mass as measured from DXA and recorded in Kg

    0, 4, 8, 12, 16 weeks

  • Change in Resting Metabolic Rate

    Resting Metabolic Rate measured via indirect calorimetry and recorded in kcal / day

    0 and 16 weeks

  • Change in Visceral Fat

    Fat in the Visceral Depot measured from DXA and recorded in Kg

    0, 4, 8, 12, 16 weeks

Study Arms (4)

Control

NO INTERVENTION

No intervention

Diet Only

EXPERIMENTAL

Subjects were given calorie and macronutrient intake goals and were told to hit those goals as closely as possible on a daily basis for 16 weeks.

Behavioral: Diet Only

Training Only

EXPERIMENTAL

Subjects were given a 3 times per week supervised resistance training program for 16 weeks

Behavioral: Training Only

Diet plus Training

EXPERIMENTAL

Subjects were given calorie and macronutrient intake goals and were told to hit those goals as closely as possible on a daily basis for 16 weeks. Subjects were given a 3 times per week supervised resistance training program for 16 weeks

Behavioral: Diet plus Training

Interventions

Diet OnlyBEHAVIORAL

Food tracking based on macronutrient goals.

Diet Only
Training OnlyBEHAVIORAL

Subjects completed 16 weeks of supervised resistance training

Training Only

Food tracking plus resistance training.

Diet plus Training

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 25-29.9 normally menstruating bodyfat \>30%

You may not qualify if:

  • currently dieting to lose weight currently engaged in structured exercise using dietary weight loss supplements Resting Metabolic Rate not within 10% of predicted value

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OverweightObesity

Interventions

Diet

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Todd A Miller, PhD

    George Washington University SPH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

March 19, 2018

First Posted

November 18, 2022

Study Start

March 18, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 18, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share