NCT04131647

Brief Summary

The identification of intermittent fasting as an alternative method to traditional weight maintenance protocols could have a significant impact on preventing body weight regain common after successful weight loss, and potentially lead to a reduction in pharmaceutical and clinical costs related to the care of overweight and obese adults.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 Progress93%
Mar 2021Oct 2026

First Submitted

Initial submission to the registry

October 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4.6 years

First QC Date

October 16, 2019

Last Update Submit

January 8, 2026

Conditions

Overweight

Keywords

ExerciseDietObesity

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight

    weight in kg

    Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up

Secondary Outcomes (3)

  • Change in Gait Speed

    Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up

  • Change in body fat

    Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance

  • Change in LPL

    Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance

Study Arms (2)

Weight Maintenance

ACTIVE COMPARATOR

Heart Healthy nutrition, walking, resistance band exercise

Other: Weight Maintenance

Weight Maintenance + Intermittent Fasting

EXPERIMENTAL

Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks.

Other: Weight Maintenance + Intermittent Fasting

Interventions

Weight Maintenance + Intermittent FastingOTHER

Following a 12-week weight loss and exercise program, subjects will participate in a weight maintenance program of Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks.

Weight Maintenance + Intermittent Fasting
Weight MaintenanceOTHER

Following a 12-week weight loss and exercise program, subjects will participate in a weight maintenance program of Heart Healthy nutrition, walking, and resistance band exercise

Weight Maintenance

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • years of age
  • BMI: 25-40 kg/m2
  • Postmenopausal status for women

You may not qualify if:

  • Uncontrolled diabetes (HbA1c \>10% or the current use of insulin)
  • Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments
  • Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease
  • Weight change within the past month of \>5 kg
  • Self-reported alcohol or drug abuse
  • Anti-coagulant medication for muscle biopsies only Impaired renal function (creatinine \> 1.5 mg/dl) History or evidence of serious liver disease (LFTs \> 2.5 x WNL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

OverweightMotor ActivityObesity

Interventions

Body Weight Maintenance

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Body WeightBody SizeGrowthGrowth and DevelopmentPhysiological Phenomena

Study Officials

  • Alice S. Ryan, PhD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Weight management program
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 18, 2019

Study Start

March 1, 2021

Primary Completion

September 30, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)