Trial Outcomes & Findings for Snack Food Reinforcement in Obese and Non-obese Women (NCT NCT00837694)

NCT ID: NCT00837694

Last Updated: 2019-08-01

Results Overview

Participants were asked to click a button on a computer mouse and after a certaion number of responses, participants would receive a point. After 5 points, the participants received a portion of snack food.

Recruitment status

COMPLETED

Target enrollment

65 participants

Primary outcome timeframe

During 2nd and 3rd visits

Results posted on

2019-08-01

Participant Flow

Women were recruited from flyers poster around campus. Interested participants called the lab and were screened by telephone.

Exclusionary criteria included smoking, current dieting, medications that could affect appetite, medical conditions that limited physical activity, allergies to or self-reported dislike of study foods.

Participant milestones

Participant milestones
Measure
Non-Obese/0 kcal
Non-obese participants that received no snack food to consume for two weeks.
Non-Obese/100 kcal
Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.
Non-obese/300 kcal
Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.
Obese/0 kcal
Obese participants that received no food to consume for two weeks.
Obese/100 kcal
Obese participants that received a 100 kcal portion of food to consume daily for two weeks.
Obese/300 kcal
Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
Overall Study
STARTED
10
11
10
11
12
11
Overall Study
COMPLETED
8
11
8
10
11
10
Overall Study
NOT COMPLETED
2
0
2
1
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Non-Obese/0 kcal
Non-obese participants that received no snack food to consume for two weeks.
Non-Obese/100 kcal
Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.
Non-obese/300 kcal
Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.
Obese/0 kcal
Obese participants that received no food to consume for two weeks.
Obese/100 kcal
Obese participants that received a 100 kcal portion of food to consume daily for two weeks.
Obese/300 kcal
Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
Overall Study
Lost to Follow-up
2
0
2
1
1
1

Baseline Characteristics

Snack Food Reinforcement in Obese and Non-obese Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Non-Obese/0 kcal
n=10 Participants
Non-obese participants that received no snack food to consume for two weeks.
Non-Obese/100 kcal
n=11 Participants
Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.
Non-obese/300 kcal
n=10 Participants
Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.
Obese/0 kcal
n=11 Participants
Obese participants that received no food to consume for two weeks.
Obese/100 kcal
n=12 Participants
Obese participants that received a 100 kcal portion of food to consume daily for two weeks.
Obese/300 kcal
n=11 Participants
Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
Total
n=65 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
11 Participants
n=7 Participants
10 Participants
n=5 Participants
11 Participants
n=4 Participants
12 Participants
n=21 Participants
11 Participants
n=8 Participants
65 Participants
n=8 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Age, Continuous
27.57 years
STANDARD_DEVIATION 7.37 • n=5 Participants
26.57 years
STANDARD_DEVIATION 9.49 • n=7 Participants
29.13 years
STANDARD_DEVIATION 7.37 • n=5 Participants
31.4 years
STANDARD_DEVIATION 2.69 • n=4 Participants
37.82 years
STANDARD_DEVIATION 2.85 • n=21 Participants
38.79 years
STANDARD_DEVIATION 3.72 • n=8 Participants
32.13 years
STANDARD_DEVIATION 10.7 • n=8 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
11 Participants
n=7 Participants
10 Participants
n=5 Participants
11 Participants
n=4 Participants
12 Participants
n=21 Participants
11 Participants
n=8 Participants
65 Participants
n=8 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
Race/Ethnicity, Customized
Minority
1 participants
n=5 Participants
1 participants
n=7 Participants
2 participants
n=5 Participants
6 participants
n=4 Participants
4 participants
n=21 Participants
3 participants
n=8 Participants
17.0 participants
n=8 Participants
Race/Ethnicity, Customized
Non-Minority
9 participants
n=5 Participants
10 participants
n=7 Participants
8 participants
n=5 Participants
5 participants
n=4 Participants
8 participants
n=21 Participants
8 participants
n=8 Participants
48.0 participants
n=8 Participants

PRIMARY outcome

Timeframe: During 2nd and 3rd visits

Participants were asked to click a button on a computer mouse and after a certaion number of responses, participants would receive a point. After 5 points, the participants received a portion of snack food.

Outcome measures

Outcome measures
Measure
Non-Obese/0 kcal
n=8 Participants
Non-obese participants that received no snack food to consume for two weeks.
Non-Obese/100 kcal
n=11 Participants
Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.
Non-obese/300 kcal
n=8 Participants
Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.
Obese/0 kcal
n=10 Participants
Obese participants that received no food to consume for two weeks.
Obese/100 kcal
n=11 Participants
Obese participants that received a 100 kcal portion of food to consume daily for two weeks.
Obese/300 kcal
n=10 Participants
Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
Number of Responses Made by Clicking a Mouse Button for Food
Number of responses at baseline
397.63 Number of button presses
Standard Error 307.6
288.36 Number of button presses
Standard Error 68.44
429.5 Number of button presses
Standard Error 307.7
213.2 Number of button presses
Standard Error 72.51
448.36 Number of button presses
Standard Error 217.49
502.00 Number of button presses
Standard Error 257.05
Number of Responses Made by Clicking a Mouse Button for Food
Number of responses visit 3
170.38 Number of button presses
Standard Error 77.48
227.27 Number of button presses
Standard Error 50.80
115.25 Number of button presses
Standard Error 46.82
147.2 Number of button presses
Standard Error 27.23
468.18 Number of button presses
Standard Error 298.40
1063.6 Number of button presses
Standard Error 670.32

PRIMARY outcome

Timeframe: visits 1, 2, and 3 plus on the phone throughout the study.

energy contained in eaten foods and beverages

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: visit 1 and visit 3

body weight

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: visits 1 and 3

height

Outcome measures

Outcome data not reported

Adverse Events

Non-Obese/0 kcal

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non-Obese/100 kcal

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non-obese/300 kcal

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Obese/0 kcal

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Obese/100 kcal

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Obese/300 kcal

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer L. Temple

University at Buffalo

Phone: 716-829-5593

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place