NCT02050165

Brief 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. The types of snacks to be studied are KIND snack bars with almonds and typical American snack foods).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 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

April 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

November 6, 2013

Last Update Submit

March 25, 2020

Conditions

Obesity

Keywords

obesitysnackssatietyhunger

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (8)

  • Body Composition

    12 Week

  • Waist circumference

    12 Week

  • Blood Pressure

    12 Week

  • Lipid Profile

    12 Week

  • Diet quality/key nutrients

    12 week

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Dietary Supplement: Typical American Snack

Interventions

KIND BarsDIETARY_SUPPLEMENT

Consumption of KIND Bars for 12 weeks

KIND Bar
Typical American SnackDIETARY_SUPPLEMENT

Consumption of typical American snacks for 12 weeks

Typical American Snack

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • David L. Katz, MD, MPH

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR

  • Valentine Y. Njike, MD, MPH

    Yale-Griffin Preventin Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

January 30, 2014

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

US(1)