ObesityNCT00328744
Reducing Snack Variety in Weight Loss Treatment
A study testing Standard and Limited Variety in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The rising prevalence of obesity in the United States is believed to be due to increased exposure to adverse environmental factors, such as food portion sizes and increased dietary variety. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard and Limited Variety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 21 and 65 years. Older adults may have more medical co-morbidities, requiring greater medical supervision. Although pediatric obesity is a significant concern, this group has different nutritional needs and requires different levels of therapist and parental involvement than are proposed.
- Body mass index (BMI) between 27 and 45 kg/m2. Based upon the Evidence Report (72), weight loss is recommended for individuals with a BMI > 25. A BMI of > 27 was chosen as eligibility criteria for this investigation because this level of BMI will allow for a 10% weight loss to occur prior to reaching a BMI of < 25. Individuals with a BMI of > 45 have more medical co-morbidities and require greater medical supervision, and thus will be considered ineligible for this investigation.
Who cannot join
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (73). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Have an allergy to a food commonly found in snack foods (i.e., nuts, milk and egg proteins).
- Report major psychiatric diseases or organic brain syndromes.
- Are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months.
- Intend to move outside of the metropolitan area within the time frame of the investigation.
- Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
- Consume < 5 different types of snack food per week. Pilot data indicated that upon screening 44 participants, mean weekly variety of snack foods was 8.7 (range 2 to 14, with only two participants consuming < 5 snack foods per week).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Snack Food Variety During Obesity Treatment
The rising prevalence of obesity in the United States is believed to be due to increased exposure to adverse environmental factors, such as food portion sizes and increased dietary variety. Although decreasing portion sizes is a strategy used in weight loss programs, research has not studied the effects of decreasing dietary variety. Cross-sectional studies show a positive association between variety and body weight and in our own studies the investigators have shown that greater reductions in the number of different snack foods (i.e., cookies, chips) consumed predicted greater decreases in overall caloric and fat intake and greater weight loss. Limiting variety may reduce intake through long-term sensory-specific satiety and/or monotony. Reducing dietary variety is a novel dietary approach with the potential to improve long-term weight loss, which has not been studied as a clinical strategy in obesity research. The objective of this application is to conduct a randomized controlled trial of a behavioral weight loss intervention limiting the number of different snack foods consumed. Two hundred overweight and obese participants will be randomized to a standard behavioral intervention (Standard) or to a standard behavioral intervention that also limits the number of different snack foods consumed (Limited Variety). Both conditions will receive an 18-month standard behavioral intervention, using behavioral techniques (i.e., self-monitoring) to change eating behaviors. Participants in the Limited Variety condition will also limit variety in snack foods to only two chosen snack foods throughout the intervention. Measures of weight, snack food consumption and hedonics, and diet satisfaction will be taken at 0, 6, 12, and 18 months. This investigation will determine:
- if the Limited Variety condition produces greater weight loss than the Standard condition at 18 months;
- if the Limited Variety condition consumes fewer servings and calories from snack foods than the Standard condition;
- if limiting snack food variety produces long-term sensory-specific satiety and/or monotony.
Relevance: Experimental studies show that limiting dietary variety profoundly reduces intake. To date, there is no dietary prescription that has been tested that capitalizes on the effect of variety on intake that can be maintained. This will be the first investigation to examine methods of manipulating dietary variety that can be adhered to over time and that influence intake, weight loss, and weight loss maintenance.
- Conditions
- Obesity
- Being tested
- Standard, Limited Variety
- Keywords
- Weight, Dietary intake, Energy, Hedonics, Behavioral, Sensory-specific satiety, Monotony
- Medical subject headings
- Obesity, Body Weight, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardBehavioural
18-month standard behavioral weight loss intervention
Limited VarietyBehavioural
Two chosen snack foods
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral: Behavioral weight loss (Standard) Receives: Behavioral: Standard |
| 2 | Experimental | Behavioral: Behavioral weight loss (Limited Variety) Receives: Behavioral: Standard; Behavioral: Limited Variety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 18 months
Secondary outcomes (2)
Diet
Measured: 18 months
Hedonics of food
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Hollie Raynor, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328744
- Sponsor's protocol ID
- R01DK074721-01
- Status last verified
- Oct 2008
- First submitted
- 19 May 2006
- Last updated
- 20 Apr 2012
- Results posted
- No
Publications
Raynor HA, Van Walleghen EL, Bachman JL, Looney SM, Phelan S, Wing RR. Dietary energy density and successful weight loss maintenance. Eat Behav. 2011 Apr;12(2):119-25. doi: 10.1016/j.eatbeh.2011.01.008. Epub 2011 Jan 25.
PubMed 21385641
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Snack Food Variety During Obesity Treatment
- ClinicalTrials.gov ID
- NCT00328744
- Acronym / sponsor ID
- R01DK074721-01
- Conditions
- Obesity
- Keywords
- Weight, Dietary intake, Energy, Hedonics, Behavioral, Sensory-specific satiety, Monotony
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rising prevalence of obesity in the United States is believed to be due to increased exposure to adverse environmental factors, such as food portion sizes and increased dietary variety. Although decreasing portion sizes is a strategy used in weight loss programs, research has not studied the effects of decreasing dietary variety. Cross-sectional studies show a positive association between variety and body weight and in our own studies the investigators have shown that greater reductions in the number of different snack foods (i.e., cookies, chips) consumed predicted greater decreases in overall caloric and fat intake and greater weight loss. Limiting variety may reduce intake through long-term sensory-specific satiety and/or monotony. Reducing dietary variety is a novel dietary approach with the potential to improve long-term weight loss, which has not been studied as a clinical strategy in obesity research. The objective of this application is to conduct a randomized controlled trial of a behavioral weight loss intervention limiting the number of different snack foods consumed. Two hundred overweight and obese participants will be randomized to a standard behavioral intervention (Standard) or to a standard behavioral intervention that also limits the number of different snack foods consumed (Limited Variety). Both conditions will receive an 18-month standard behavioral intervention, using behavioral techniques (i.e., self-monitoring) to change eating behaviors. Participants in the Limited Variety condition will also limit variety in snack foods to only two chosen snack foods throughout the intervention. Measures of weight, snack food consumption and hedonics, and diet satisfaction will be taken at 0, 6, 12, and 18 months. This investigation will determine:
- if the Limited Variety condition produces greater weight loss than the Standard condition at 18 months;
- if the Limited Variety condition consumes fewer servings and calories from snack foods than the Standard condition;
- if limiting snack food variety produces long-term sensory-specific satiety and/or monotony.
Relevance: Experimental studies show that limiting dietary variety profoundly reduces intake. To date, there is no dietary prescription that has been tested that capitalizes on the effect of variety on intake that can be maintained. This will be the first investigation to examine methods of manipulating dietary variety that can be adhered to over time and that influence intake, weight loss, and weight loss maintenance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: StandardBehavioral: Behavioral weight loss (Standard) |
| 2 | Experimental | Behavioral: Standard, Behavioral: Limited VarietyBehavioral: Behavioral weight loss (Limited Variety) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 21 and 65 years. Older adults may have more medical co-morbidities, requiring greater medical supervision. Although pediatric obesity is a significant concern, this group has different nutritional needs and requires different levels of therapist and parental involvement than are proposed.
- Body mass index (BMI) between 27 and 45 kg/m2. Based upon the Evidence Report (72), weight loss is recommended for individuals with a BMI > 25. A BMI of > 27 was chosen as eligibility criteria for this investigation because this level of BMI will allow for a 10% weight loss to occur prior to reaching a BMI of < 25. Individuals with a BMI of > 45 have more medical co-morbidities and require greater medical supervision, and thus will be considered ineligible for this investigation.
Key exclusion criteria (7 listed)
- Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q) (73). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Have an allergy to a food commonly found in snack foods (i.e., nuts, milk and egg proteins).
- Report major psychiatric diseases or organic brain syndromes.
- Are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months.
- Intend to move outside of the metropolitan area within the time frame of the investigation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard18-month standard behavioral weight loss intervention | Behavioural | 1, 2 |
| Limited VarietyTwo chosen snack foods | Behavioural | 2 |
Primary outcome
Weight loss
Time frame: 18 months
2 secondary outcomes
Diet
Time frame: 18 months
Hedonics of food
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
- Derived from this study: PubMed 21385641Raynor HA, Van Walleghen EL, Bachman JL, Looney SM, Phelan S, Wing RR. Dietary energy density and successful weight loss maintenance. Eat Behav. 2011 Apr;12(2):119-25. doi: 10.1016/j.eatbeh.2011.01.008. Epub 2011 Jan 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hollie Raynor, PhD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard and Limited Variety in people with Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00328744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.