NCT01645956

Brief Summary

The importance of exercise for weight control is well documented; however if exercise results in an increase in food intake, the beneficial effect of exercise may not be seen. This study addresses a gap in the current literature and examines why some people eat more after exercise and why some people eat less and also examines whether these responses are consistent over time. Participants in this study will be asked to come to our center on 7 different occasions over a 3-4 month period. The first visit will be an assessment visit where body weight and body composition will be measured, questionnaires will be completed, and an exercise test will be performed. During the remaining 6 visits (3 pairs of sessions with visits in each pair separated by 48-96 hours) the procedures will be nearly identical. Upon arrival at our center, participants will consume a meal replacement, complete a series of questionnaires and then either rest or walk on a treadmill for 30 minutes (3 days will be resting and 3 will be exercising). One hour following the exercise/resting session, individuals will be given access to a buffet of food, unaware that their food intake will be monitored. All food will be weighed and measured before and after the eating period and the amount of food consumed after each pair of exercise and resting conditions will be compared to one another. It is hypothesized that the difference in food intake will be consistent across pairs of testing sessions. Findings from this study will help us to better understand the relationship between exercise and food intake and may ultimately lead to future studies that can address the clinically significant question of why some individuals gain weight and others lose weight when engaging in exercise training programs. Findings from this study may also help to develop exercise programs that maximize the beneficial effect of exercise on body weight.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

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

July 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 19, 2015

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

July 18, 2012

Last Update Submit

February 18, 2015

Conditions

Keywords

obesityexerciseenergy intakephysical activity

Outcome Measures

Primary Outcomes (1)

  • energy intake

    1 hour post exercise/rest

Study Arms (1)

Single group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Relatively sedentary (exercising less than 60 minutes/week over the past 6 months) overweight and obese (BMI: 25.0 to \<35.0 kg/m2) women between the ages of 18 and 45.

You may qualify if:

  • Age 18-45 years
  • BMI between 25.0 and \<35.0 kg/m2
  • Female
  • Sedentary, defined as exercising at a moderate-intensity for less than 60 minutes/week over the past 6 months.

You may not qualify if:

  • Presence of any condition that would limit one's ability from exercising (i.e., orthopedic limitations)
  • Recent weight gain or weight loss (± 10 pounds within the past 6 months)
  • Currently enrolled in a weight loss program
  • History of heart disease or diabetes
  • Currently taking any medication that would alter heart rate (e.g., beta blocker) or metabolism
  • Women who are pregnant, planning on becoming pregnant in the next 2 months, or those pregnant within the past 6 months
  • Uncontrolled hypertension (currently taking blood pressure medication or having a resting systolic blood pressure ≥140/90 mmHg
  • Get an average of \<6 hours of sleep/night
  • Does not currently eat breakfast regularly
  • Known food allergies to test foods or states a disliking or unwillingness to eat more than 25% of the buffet foods.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

ObesitySedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jessica L Unick, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2012

First Posted

July 20, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 19, 2015

Record last verified: 2012-07

Locations