Snack Food Reinforcement in Obese and Non-obese Women

• Sponsor: State University of New York at Buffalo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00837694
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

Food reinforcement, motivation to obtain food, is associated with energy intake and obesity. Finding ways to decrease the reinforcing value of unhealthy foods may help with adherence to diets and weight loss. Our previous study in non-obese adults showed that daily consumption of the same snack food (food typically consumed outside of meals) for 14 days significantly decreased its reinforcing value. The purpose of this study was to replicate and extend these findings to obese individuals as well as to examine effects of different portion sizes of snack foods on food reinforcement. Thirty-one obese (body mass index > 30 kg/m2) and 27 non-obese (BMI < 30 kg/m2) women had food reinforcement and liking tested at baseline and after two weeks of daily consumption of either 0 kcal, 100 kcals, or 300 kcals daily of the same snack food.

Condition or Disease	Intervention/Treatment	Phase
Obesity

Study Design

• Study Type: Observational
• Actual Enrollment: 65 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Differential Effects of Daily Snack Food Intake on Reinforcing Value of Food in Obese and Non-obese Women.
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1 Non-obese/0 kcal
2 Non-obese/100 kcal
3 Non-obese/300 kcal
4 Obese/0 kcal
5 Obese/100 kcal
6 Obese/300 kcal

Outcome Measures

Primary Outcome Measures

1. Number of Responses Made by Clicking a Mouse Button for Food [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.

2. Energy Intake [visits 1, 2, and 3 plus on the phone throughout the study.]

   energy contained in eaten foods and beverages

Secondary Outcome Measures

1. Body Weight [visit 1 and visit 3]

   body weight

2. Height [visits 1 and 3]

   height

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• women

• non-smoker

• not on a diet

• no restrained eating

• had to like potential snack foods

• willing to visit the laboratory 3 times

• willing to eat snacks provided

• no medications or medical conditions that affect appetite

• no food allergies

Exclusion Criteria:

• see above

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University at Buffalo	Buffalo	New York	United States	14214

Sponsors and Collaborators

• State University of New York at Buffalo

Investigators

• Principal Investigator: Jennifer L Temple, Ph.D., University at Buffalo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Temple, Assistant Professor, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT00837694
• Other Study ID Numbers: Temple1
• First Posted: Feb 5, 2009
• Last Update Posted: Aug 1, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Jennifer Temple, Assistant Professor, State University of New York at Buffalo: BMI; obesity; sensitization; food reinforcement; snack food; Portion size of daily snacks; Weight status
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Recruitment Details	Women were recruited from flyers poster around campus. Interested participants called the lab and were screened by telephone.
Pre-assignment Detail	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.

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

Baseline Characteristics

Arm/Group Title	Non-Obese/0 kcal	Non-Obese/100 kcal	Non-obese/300 kcal	Obese/0 kcal	Obese/100 kcal	Obese/300 kcal	Total
Arm/Group Description	Non-obese participants that received no snack food to consume for two weeks.	Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.	Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.	Obese participants that received no food to consume for two weeks.	Obese participants that received a 100 kcal portion of food to consume daily for two weeks.	Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.	Total of all reporting groups
Overall Participants	10	11	10	11	12	11	65
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	11 100%	10 100%	11 100%	12 100%	11 100%	65 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.57 (7.37)	26.57 (9.49)	29.13 (7.37)	31.4 (2.69)	37.82 (2.85)	38.79 (3.72)	32.13 (10.7)
Sex: Female, Male (Count of Participants)
Female	10 100%	11 100%	10 100%	11 100%	12 100%	11 100%	65 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Minority	1 10%	1 9.1%	2 20%	6 54.5%	4 33.3%	3 27.3%	17.0 26.2%
Non-Minority	9 90%	10 90.9%	8 80%	5 45.5%	8 66.7%	8 72.7%	48.0 73.8%

Outcome Measures

1. Primary Outcome

Title	Number of Responses Made by Clicking a Mouse Button for Food
Description	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.
Time Frame	During 2nd and 3rd visits

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-Obese/0 kcal	Non-Obese/100 kcal	Non-obese/300 kcal	Obese/0 kcal	Obese/100 kcal	Obese/300 kcal
Arm/Group Description	Non-obese participants that received no snack food to consume for two weeks.	Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.	Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.	Obese participants that received no food to consume for two weeks.	Obese participants that received a 100 kcal portion of food to consume daily for two weeks.	Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
Measure Participants	8	11	8	10	11	10
Number of responses at baseline	397.63 (307.6)	288.36 (68.44)	429.5 (307.7)	213.2 (72.51)	448.36 (217.49)	502.00 (257.05)
Number of responses visit 3	170.38 (77.48)	227.27 (50.80)	115.25 (46.82)	147.2 (27.23)	468.18 (298.40)	1063.6 (670.32)

2. Primary Outcome

Title	Energy Intake
Description	energy contained in eaten foods and beverages
Time Frame	visits 1, 2, and 3 plus on the phone throughout the study.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Body Weight
Description	body weight
Time Frame	visit 1 and visit 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Height
Description	height
Time Frame	visits 1 and 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Non-Obese/0 kcal		Non-Obese/100 kcal		Non-obese/300 kcal		Obese/0 kcal		Obese/100 kcal		Obese/300 kcal
Arm/Group Description	Non-obese participants that received no snack food to consume for two weeks.		Non-obese participants that received a 100 kcal portion of food to consume daily for two weeks.		Non-obese participants that received a 300 kcal portion of food to consume daily for two weeks.		Obese participants that received no food to consume for two weeks.		Obese participants that received a 100 kcal portion of food to consume daily for two weeks.		Obese individuals who received a 300 kcal portion of food to consume for 2 weeks.
All Cause Mortality
	Non-Obese/0 kcal		Non-Obese/100 kcal		Non-obese/300 kcal		Obese/0 kcal		Obese/100 kcal		Obese/300 kcal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Non-Obese/0 kcal		Non-Obese/100 kcal		Non-obese/300 kcal		Obese/0 kcal		Obese/100 kcal		Obese/300 kcal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)		0/10 (0%)		0/11 (0%)		0/12 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Non-Obese/0 kcal		Non-Obese/100 kcal		Non-obese/300 kcal		Obese/0 kcal		Obese/100 kcal		Obese/300 kcal
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)		0/10 (0%)		0/11 (0%)		0/12 (0%)		0/11 (0%)

Limitations/Caveats

One limitation was that we relied on self-report for energy and snack food intake. It is possible that people were not eating the food that they said they were. Another limitation was that people may have not understood the task.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.