ObesitySnackNCT02050165
Snacking, Satiety &Weight: A Randomized, Controlled Trial
A study testing KIND Bars and Typical American Snack in people with Obesity, run by Griffin Hospital at 1 site in United States.
Trial summary
Proposed is a parallel-design randomized controlled trial to compare the effects of consuming two types of snacks on a daily basis for a 12-week period on health outcomes, diet quality, and self-reported satiety in a group of overweight adults. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- KIND Bars and Typical American Snack
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2013
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman age 25-75 years;
- Non-smoker;
- Sedentary;
- Overweight (BMI ≥25kg/m²) with waist circumference >40 inches (102 cm) for men and >35 inches (88 cm) for women;
- Interested in losing weight, but not actively involved with a diet or weight loss program.
- Snack regularly with pre-packaged snacks typically available in grocery stores or vending machines.
- Willing to consume snacks on a daily basis.
Who cannot join
- Failure to meet inclusion criteria;
- Anticipated inability to complete study protocol for any reason;
- Current eating disorder;
- Diabetes;
- Sleep apnea;
- Actively involved with a diet or weight loss program;
- Other restricted diets due to allergy/intolerance (i.e. nut, gluten) or by choice (i.e., vegetarian, vegan);
- Regular exercise as defined by participating in moderate-intensity for at least 150 minutes/week.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-Griffin Prevention Research Center
Derby, Connecticut, 06418
About this study
Proposed is a parallel-design randomized controlled trial to compare the effects of consuming two types of snacks on a daily basis for a 12-week period on health outcomes, diet quality, and self-reported satiety in a group of overweight adults. The types of snacks to be studied are KIND snack bars with almonds and typical American snack foods).
Read the detailed description
Snacking has been implicated in the obesity epidemic, but judicious snacking can help control appetite and calorie intake and add nutrient-dense foods to the diet. The investigators hypothesize that snacking on nutrient-dense, highly satiating snack foods (i.e. KIND snacks with almonds) as compared to snacking on nutrient-dilute, energy-dense foods (i.e., conventional snack foods) will contribute to satiety, weight loss, and health improvements. The investigators further hypothesize that the benefits of healthful snacking are enhanced when portion is clearly defined and controlled by packaging. Finally, the investigators hypothesize that these effects will be seen even when study participants are given clear guidance about the calorie content of snack items, and how to make room for those calories in their diets.
Hypotheses:
- Snacking on nutrient-dense, highly satiating snack foods (i.e. KIND snacks with almonds) as compared to snacking on nutrient-dilute, energy-dense foods (i.e., conventional snack foods) will contribute to satiety, weight loss, and health improvements.
- The benefits of healthful snacking are enhanced when portion size is clearly defined and controlled by packaging.
- These effects will be seen even when study participants are given clear guidance about the calorie content of snack items, and how to make room for those calories in their diets.
- Conditions
- Obesity
- Being tested
- KIND Bars, Typical American Snack
- Keywords
- obesity, snacks, satiety, hunger
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIND BarsDietary supplement
Consumption of KIND Bars for 12 weeks
Typical American SnackDietary supplement
Consumption of typical American snacks for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| KIND Bar | Experimental | Daily inclusion of KIND Bars with almonds as a primary ingredient as part of the participant's usual diet, with diet counseling to adjust for the calories from the KIND Bars. KIND Bars that we will use in the study will include: Dark Chocolate Chili Almond; Cranberry Almond; Almond Walnut Macadamia; Pomegranate Blueberry Pistachio; Nut Delight; Fruit and Nut Delight; Almond and Apricot; Blueberry Pecan and Fiber. Receives: Dietary Supplement: KIND Bars |
| Typical American Snack | Experimental | Daily inclusion of conventional snacks (as part of the participant's usual diet, with diet counseling to adjust for the calories from the snacks. The snacks will consist of cookies considered to be conventional snack foods that are nutrient-dilute (i.e. relatively low in nutrients) and energy-dense (i.e., relatively high in kcal). Examples of conventional snack foods will include: Nabisco Snackwell Creme Sandwich 1.7 oz pack, Nabisco Newtons Fig 2 oz pack, Nabisco Cips Ahoy! Chocolate Chip 1.4 oz pack, and Nabisco Oreo Double Stuff Chocolate 1.3 oz pack. Receives: Dietary Supplement: Typical American Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Body mass index (BMI) will be calculated as weight (kg) divided by height in meters (m) squared. Waist circumference will be measured using guidelines of the National Obesity Expert Panel Report.
Measured: 12 weeks
Secondary outcomes (8)
Body Composition
Body composition will be measured using bioelectrical impedance analysis, which uses the resistance of electrical flow through the body to estimate body fat. The Body Composition Analyzer measures weight and calculates body fat% and total body water% in addition to BMI.
Measured: 12 Week
Waist circumference
The waist circumference will be measured using the U.S. government standard protocol. Waist circumference will be measured around the narrowest point between ribs and hips when viewed from the front after exhaling.
Measured: 12 Week
Blood Pressure
Blood pressure will be measured by using a Dinamap Monitor Pro 100 (after sitting for 5 minutes). Both systolic and diastolic pressures will be calculated as the mean value of 2 readings 5 minutes apart for each participant at every time point of assessment.
Measured: 12 Week
Lipid Profile
The lipid profile is determined as follows: Total cholesterol , triglycerides, and high-density lipoprotein are obtained by direct measurements. Very-low-density lipoprotein (VLDL) and low-density-lipoprotein (LDL) are obtained by calculation.
Measured: 12 Week
Diet quality/key nutrients
Diet quality as measured by the Healthy Eating Index-2005 (HEI). A 24-hour recall will be used to assess dietary intake of all participants, and we will calculate an HEI score from each completed recall.
Measured: 12 week
Hunger/Satiety
Hunger and satiety will be assessed using a Visual Analog Scale (VAS) which will ask participants a series of questions to be completed at a predetermined time relative to consumption of the treatment snack. The questions of the VAS require participants to rate on a scale the strength of specific sensations that they are feeling (i.e., hunger, thirst, amount of food that they could eat "right now", nausea, and fullness) by placing a vertical mark on the scale in response to each question.
Measured: 12 Week
Quality of Life
The Short Form (SF)-12 version 2.0 will be used to assess quality of life of our study participants. The SF-12 contains 12 items from the SF-36 Health Survey. The SF-12 contains one or two items that measure each of the eight concepts included in the SF-36. Like the SF-36, the SF-12 is available in standard (4-week recall) and acute (1-week recall) formats. The SF-12 standard will be used to assess the quality of life of participants.
Measured: 12 Week
Physical Activity
Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ) Short Form. The IPAQ is a valid and reliable tool to assess physical activity in adults. It is a more comprehensive tool containing information on weekly activities in household and yard-work activities, occupational activity, transport, leisure time physical activity and sedentary behavior.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kind LLC
- Responsible party
- Sponsor
- Investigators
- David L. Katz, MD, MPH, Principal investigator, Yale-Griffin Prevention Research CenterValentine Y. Njike, MD, MPH, Principal investigator, Yale-Griffin Preventin Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050165
- Sponsor's protocol ID
- 2013-01
- Acronym
- Snack
- Status last verified
- Mar 2020
- First submitted
- 6 Nov 2013
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snacking, Satiety &Weight: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02050165
- Acronym / sponsor ID
- Snack / 2013-01
- Conditions
- Obesity
- Keywords
- obesity, snacks, satiety, hunger
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Collaborators
- Kind LLC
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Jan 2014 (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.
Proposed is a parallel-design randomized controlled trial to compare the effects of consuming two types of snacks on a daily basis for a 12-week period on health outcomes, diet quality, and self-reported satiety in a group of overweight adults. The types of snacks to be studied are KIND snack bars with almonds and typical American snack foods).
Detailed description
Snacking has been implicated in the obesity epidemic, but judicious snacking can help control appetite and calorie intake and add nutrient-dense foods to the diet. The investigators hypothesize that snacking on nutrient-dense, highly satiating snack foods (i.e. KIND snacks with almonds) as compared to snacking on nutrient-dilute, energy-dense foods (i.e., conventional snack foods) will contribute to satiety, weight loss, and health improvements. The investigators further hypothesize that the benefits of healthful snacking are enhanced when portion is clearly defined and controlled by packaging. Finally, the investigators hypothesize that these effects will be seen even when study participants are given clear guidance about the calorie content of snack items, and how to make room for those calories in their diets.
Hypotheses:
- Snacking on nutrient-dense, highly satiating snack foods (i.e. KIND snacks with almonds) as compared to snacking on nutrient-dilute, energy-dense foods (i.e., conventional snack foods) will contribute to satiety, weight loss, and health improvements.
- The benefits of healthful snacking are enhanced when portion size is clearly defined and controlled by packaging.
- These effects will be seen even when study participants are given clear guidance about the calorie content of snack items, and how to make room for those calories in their diets.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIND Bar | Experimental | Dietary Supplement: KIND BarsDaily inclusion of KIND Bars with almonds as a primary ingredient as part of the participant's usual diet, with diet counseling to adjust for the calories from the KIND Bars. KIND Bars that we will use in the study will include: Dark Chocolate Chili Almond; Cranberry Almond; Almond Walnut Macadamia; Pomegranate Blueberry Pistachio; Nut Delight; Fruit and Nut Delight; Almond and Apricot; Blueberry Pecan and Fiber. |
| Typical American Snack | Experimental | Dietary Supplement: Typical American SnackDaily inclusion of conventional snacks (as part of the participant's usual diet, with diet counseling to adjust for the calories from the snacks. The snacks will consist of cookies considered to be conventional snack foods that are nutrient-dilute (i.e. relatively low in nutrients) and energy-dense (i.e., relatively high in kcal). Examples of conventional snack foods will include: Nabisco Snackwell Creme Sandwich 1.7 oz pack, Nabisco Newtons Fig 2 oz pack, Nabisco Cips Ahoy! Chocolate Chip 1.4 oz pack, and Nabisco Oreo Double Stuff Chocolate 1.3 oz pack. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Man or woman age 25-75 years;
- Non-smoker;
- Sedentary;
- Overweight (BMI ≥25kg/m²) with waist circumference >40 inches (102 cm) for men and >35 inches (88 cm) for women;
- Interested in losing weight, but not actively involved with a diet or weight loss program.
Key exclusion criteria (8 listed)
- Failure to meet inclusion criteria;
- Anticipated inability to complete study protocol for any reason;
- Current eating disorder;
- Diabetes;
- Sleep apnea;
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 |
|---|---|---|
| KIND BarsConsumption of KIND Bars for 12 weeks | Dietary supplement | KIND Bar |
| Typical American SnackConsumption of typical American snacks for 12 weeks | Dietary supplement | Typical American Snack |
Primary outcome
Body Mass Index
Time frame: 12 weeks
Body mass index (BMI) will be calculated as weight (kg) divided by height in meters (m) squared. Waist circumference will be measured using guidelines of the National Obesity Expert Panel Report.
8 secondary outcomes
Body Composition
Time frame: 12 Week
Waist circumference
Time frame: 12 Week
Blood Pressure
Time frame: 12 Week
Lipid Profile
Time frame: 12 Week
Diet quality/key nutrients
Time frame: 12 week
Hunger/Satiety
Time frame: 12 Week
Quality of Life
Time frame: 12 Week
Physical Activity
Time frame: 12 week
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 26 Mar 2020.
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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.
David L. Katz, MD, MPH principal investigator
Yale-Griffin Prevention Research Center
Valentine Y. Njike, MD, MPH principal investigator
Yale-Griffin Preventin Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KIND Bars and Typical American Snack in people with Obesity, run by Griffin 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 7 inclusion and 8 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 26 Mar 2020. 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?
Body Mass Index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2020.